WO2015153291A1

WO2015153291A1 - Devices for the intraocular treatment of refractive error

Info

Publication number: WO2015153291A1
Application number: PCT/US2015/022778
Authority: WO
Inventors: David Maxwell Kleinman
Original assignee: Cataract Innovations Llc
Priority date: 2014-03-31
Filing date: 2015-03-26
Publication date: 2015-10-08

Abstract

A novel intraocular lens for the treatment of refractive error in an aphakic or pseudophakic eye is disclosed. The novel intraocular lens has a retention strut that allows for accurate and secure placement of the lens inside the eye. The retention strut has a proximal end that is joined to a lens and a distal end that is not joined to the lens. The retention strut extends away from the lens and is capable of engaging and penetrating at least one capsular leaflet of the eye. The retention strut may have a wedge or similar structure to aid in the penetration and engagement of a capsular leaflet of the eye. Progression blockers or similar structures may also be provided along the retention strut to ensure proper continued placement of the retention strut in a capsular leaflet. A specially designed instrument can assist with placement of the lens.

Description

DEVICES FOR THE INTRAOCULAR TREATMENT OF REFRACTIVE ERROR

CROSS REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority to United States Patent Application Serial No.

61/973,183 filed March 31, 2014 entitled "Apparati And Methods For The Treatment Of Refractive Error Including Ametropia, Presbyopia And Optical Aberrations In A Pseudophakic Eye" by Dr. David M. Kleinman the entire disclosure of which is incorporated herein by reference as permissible by national or regional laws.

TECHNICAL FIELD

This invention relates generally to surgery of the eye, and more particularly to intraocular lenses and surgical instrumentation and other devices for the treatment of refractive error in aphakic and pseudophakic eyes.

BACKGROUND ART

Presbyopia is a condition in which the lens of the eye loses its ability to change its focus, such that when the eye is corrected at distance, it is difficult to see objects up close. A similar process occurs after a patient is treated for cataract with the removal of the natural cloudy lens and placement of a single power, non-premium artificial intraocular lens (IOL). An IOL can be placed in the anterior chamber or posterior chamber of the eye. Current approaches to pseudophakic presbyopia include the placement of premium IOL's. A premium IOL addresses the near focus problem with either a multifocal lens or an accommodating lens. An accommodating lens changes shape or position to help focus at near. A multifocal IOL brings several different distances into focus at once. The standard for IOL surgery is to place a single power, non-premium IOL in the eye with the focus set for distance. Typically the accommodating and multifocal IOL's are also chosen based on their power for optimal distance acuity, and then through accommodation or multiple focal planes the near vision is improved. Another approach to presbyopia in pseudophakes includes monovision (where the eyes are set at different distances). An additional approach is corneal surgery where either a small intracorneal ring is placed to provide a pinhole effect centrally which can be used for phakic and pseudophakic patients, and a small power lens can be placed in the central intracorneal space as well. Presbyopia is a huge concern globally. Anyone older than approximately age 40 or 45 will develop presbyopia when fully corrected at distance. The problem of presbyopia is very common in patients who have undergone cataract surgery, especially those who received a single power IOL. Approximately 2.5 million Americans undergo cataract surgery^' annually and the majority receive a single vision power lens. There is a backlog of millions of people who have received a single vision IOL who now must use reading glasses for presbyopia.

Another major issue facing cataract patients involves the final or postoperative refractive error. Generally the cataract surgeon selects a postoperative refraction close to piano correction at distance. Other times a patient may request a slightly myopic status. This choice can be based on the concern that a mild overcorrection could lead to hyperopia which is unsatisfactory because refractive correction is required at all times, whereas myopes can see at some distance in focus. Thus, a first problem after cataract surgery is an unexpected hyperopic outcome. In this case, a lens exchange is considered. Another problem that can occur is that the wrong lens was placed, or ocular biometry predicted a much different result than was actually identified after cataract surgery and placement of the IOL. For example, a patient could end up much more myopic than desired. Again, an IOL exchange would be considered. Third, multifocal and accommodating IOL's have much less room for error when determining the proper lens for placement in the eye. Thus, in the case where a multifocal or accommodating IOL is placed, and the power is not exactly correct, the patient may be dissatisfied. It is not desirable generally to remove and replace IOL's, and the challenges are even greater with premium IOL's which required substantial out-of-pocket patient costs. A new approach to simply correct these issues with a minimally invasive procedure would add significant value to the surgical choices cataract surgeons can offer their patients. Another situation where such an approach would prove useful is in the setting of monocular cataract or asymmetric cataract in a subject with a refractive error. In order to avoid binocular diplopia or aniseikonia the power differences between the lenses of the two eyes should be roughly 2.5 diopters or less. Thus, a significant issue is exemplified by the following case. A bilateral -6.0 diopter myope has an asymmetric cataract. Cataract extraction is indicated for one eye only. Under this scenario, the cataract surgeon can at best leave the surgerized eye at a correction of -3.0 diopters so that binocular vision can be tolerated. However, the optimal long term result for this subject once the other cataract matures and is operated on is to have each eye corrected close to piano. Because of this issue, sometimes cataract surgery is performed in both eyes, even the eye without a visually significant cataract so that a proper bilateral correction is placed. There would be value in allowing the cataract surgeon to operate only on the affected eye, correct it with an IOL close to the other eye's native power, and then when the second eye is operated on (perhaps years later), a simple corrective procedure can be performed to correct the first eye's refractive error so the end result is satisfactory correction at distance for both eyes (piano, slightly myopic, or whatever ^'the patient or surgeon prefers). Another situation where this invention may be of benefit is following scleral buckling surgery whereby the eye is elongated and the eye made more myopic for a pseudophake— the present approach can be a preferred alternative to additional spectacle myopic correction. Such an advance would give added flexibility and safe options to the cataract surgeon and patient with cataract.

The current invention describes a novel apparatus and lens for treating millions of individuals suffering from presbyopia following cataract or IOL surgery. The same approach (instrumentation and lens) provides a simple and minimally invasive surgical technique to correct situations where the IOL power needs changing, and in some embodiments also reduces the need for precise refractive correction. The invention can also provide an opportunity to improve sight, generally, with customized correction. Although alternatives such as LASI (Laser Assisted in situ Keratomileusis) exist, there are other clinical situations where the novel technology described herein has value.

One might ask, what is wrong with current piggyback lens technology? Can't a simple piggyback lens do the same thing? The answer is no. A piggyback lens can be effective, but there is room for improvement on existing piggyback IOL technologies. The ability to place the novel IOL with retention struts (described herein) easily and securely to correct vision problems would benefit many surgeons and their patients.

Cataract is one of the leading causes of visual disturbance worldwide. Cataract can be effectively treated with cataract extraction (CE) which is removal of the cataract by surgery. An intraocular lens (IOL) is typically placed. Extracapsular cataract extraction (ECCE) with placement of a posterior chamber intraocular lens (PCIOL) involves entering into the capsule to get to the cataract. The capsule is entered via a capsulotomy or a capsulorhexis. The opening for the central capsulotomy to access the lens is typically several millimeters (mm) in widest diameter. Phacoemulsification can be used to remove the cataract from the eye. The optic of an IOL can fit through the opening. (Note, this capsulotomy that provides access to the natural lens for removal is different from the small capsulotomy holes described herein for engagement of a protrusion from a novel IOL.) The PCIOL can be placed in the capsular bag or in the sulcus. In both cases there is capsular tissue in the eye which helps support the posterior chamber intraocular lens. In cases of phacoemulsification and lens removal, a posterior chamber intraocular lens is placed. As with ECCE, the posterior chamber lens can be placed in the capsular bag or in the sulcus. In both cases there is capsular tissue in the eye which helps support the posterior chamber intraocular lens. An eye that lias a replacement, plastic intraocular lens is called a pseudophakic eye. Pseudophakia can be used to describe this condition. In some situations, whether deliberate (high myopia) or due to surgical challenges, the patient is left without a PCIOL. This condition is termed aphakia. Cataract and IOL surgery are generally very effective. However, there are situations where a patient is left with refractive abnormalities, visual symptoms, or a desire for better visual performance. It is the conditions of pseudophakia and aphakia that this novel lenses and surgical apparati are designed to treat.

When IOL surgery is performed, the residual or post-operative refractive power of the eye is determined in large part by the power (strength in diopters, for example) of the IOL that is placed. The surgeon may aim or target a specific post-operative refractive power. For example, some surgeons target emmetropia (no correction required at distance), while another surgeon may target slight myopia to decrease the risk of overcorrection which can lead to patient dissatisfaction. It is often the case that the actual post cataract extraction/IOL surgery refractive error is different from the targeted refractive error. There can be many reasons to explain the discrepancy. For example, the pre-operative measurements could have been slightly different from the true measurements of the eye. The length could be different than measured, or the corneal power could be different than measured. Furthermore, a lens different from the intended lens could be placed. There also could be induction of astigmatism from the surgery. The IOL may sit in the eye in a position anterior or posterior to the intended position. Other factors include difficulty measuring an eye that has had previous refractive surgery or instability of corneal curvature in contact lens wearers. The IOL may tilt or position off axis and that may affect focusing power.

Another issue is distance vision and near vision. If a patient is targeted for perfect or excellent distance correction (emmetropia), it is very likely that the post-operative (after cataract extraction/IOL) eye will not focus well for objects at near. Thus, in a standard setting, the post-cataract/IOL patient will need to use some type of over- correction for near. Likewise, if the eye is targeted to see well at near without glasses, then the vision will not be acceptable at distance without glasses or contacts. In short, if a patient has a single power, non-premium IOL, there will be some situation (distance or near) that is not in focus at a given time.

Patients, however, may obtain a premium IOL. A premium IOL is typically one of two types: accommodating or multifocal. If a patient gets a premium IOL placed, the problems of near and distance vision refractive differences are addressed to some degree. In other words, in the setting of a multifocal IOL, both near and distance correction are built into a single IOL. In the case of an accommodating IOL, of which there are many designs, the IOL changes power when the subject looks at near versus the power of the lens at distance. There can be many technical methods to address this type of pseudo or real IOL accommodation. In some cases the lens itself moves anteriorly and posteriorly. In other cases the power of the lens (by different mechanisms) changes when the ciliary muscle changes its contractile state as the eye changes gaze from far to near.

In any event, even in the setting of premium IOL surgery there are situations where post- operative patients are not satisfied. The image quality can be suboptimal at both near and far, there may be haloes or glare. A critical factor in premium IOL surgery is predicted post operative refraction. A surgeon aims for a very precise target (such as emmetropic) in premium IOL surgery, whereas in single power, it is generally acceptable to target -0.50 to -1.0 diopters. Such a broad range for refractive targeting does not lead to the best performance for premium IOLs. Other issues include lens decentration, and astigmatism. In many situations, patients generally find some dissatisfaction following premium IOL surgery. There are many reasons for dissatisfaction following premium IOL surgery, and significant room for improvement in patient outcomes. The approaches to the eye using the novel IOL and insertion device described herein offer solutions for patients with dissatisfaction after premium IOL surgery. The approaches to the eye using the novel IOL and insertion device described herein offer alternatives to patients considering premium IOL surgery. The approaches to the eye using the novel IOL and insertion device described herein address an unmet need in the cataract, refractive, and burgeoning higher-order correction market landscape in ophthalmology. The approaches to the eye using the novel IOL and insertion device described herein, in some embodiments using piggyback type-positioning, provide an opportunity to correct the eyes post operative power, correct for astigmatism, correct higher-order aberrations, correct for lens decentration, and improve vision generally.

In some patients, there is no pupil, or the iris is torn or damaged. In some embodiments the novel IOL technology described herein addresses an unmet need for a patient who will benefit from the creation of an artificial pupil in the eye.

In single power IOL surgery, patients are generally quite satisfied with best corrected vision. There are still opportunities to improve upon outcomes. For one, there are many active post- cataract surgery patients who would benefit from less reliance on glasses generally, or distance or reading glasses specifically. The approaches to the eye using the novel IOL and insertion device described herein address an unmet need for patients who currently have single power IOL correction. The approaches to the eye using the novel IOL and insertion device described herein provide an opportunity for presbyopic correction, multifocal correction, astigmatic correction, higher order correction, lens decentration correction, and correction of glare and other symptoms.

The approaches to the eye using the novel IOL and insertion device described herein address an unmet need in the cataract, refractive, and burgeoning higher-order correction market landscape in ophthalmology. The combination of a single power IOL with eyelets, and then a secondary approach to residual refractive error is a sound technique for vision restoration after cataract surgery. For example, once a standard power IOL is in place, a secondary approach to correction of residual spherical power as well as astigmatic correction has value. That secondary correction coupled with a multifocal, or small central presbyopic corrective lens placed directly in the visual axis of the eye, adds additional value. The novel technology is amenable to precise placement of a lens in an eye with a capsule. The precise placement enhances optical performance, and precise placement is indeed required for astigmatic, irregular astigmatism, and higher order correction. Precise central placement of the novel IOL with retention struts conveys benefits that are uniquely challenging because centration and stabilization of an IOL in the eye is not always simple. The lens of the present invention solves stabilization issues in a novel way. The visual axis of the eye can be determined by observation and/or with advanced imaging or analysis technology. A precise small hole can be made in the lens capsule in a manner such that when the retention strut is placed through that hole, the optic will be centered. A trailing haptic or second retention strut, depending on the embodiment, further serves to secure the novel lens in the proper position. Another advantage inherent to this invention is ease of placement. In some embodiments of the present invention the lens is placed in the eye through a novel instrument such that fewer steps than currently used for secondary IOL surgery are required. For example, the combination of the insertion instrument with a keratotomy blade and infusion allows for a streamlined procedure. The same instrument that makes the incision enters the eye and maintains the anterior chamber. The novel lens is advanced, guided into the small capsulotomy hole, and the lens is deployed. A small secondary tool or instrument helps position the IOL if adjustments are needed. In some embodiments, the insertion instrument has some but not all characteristics described herein. The expandable nature of the retention strut in some embodiments allows for secure capture between IOL and capsule. The other retention strut or optic attributes described herein enhance performance and stabilization, either in combination with an expandable retention strut, or on their own.

There are many aspects of the current inventions that address unmet needs and have utility in ophthalmology. The key aspect of engaging a thin membrane in a penetrating manner to stabilize an optic or intraocular lens is new, as is engaging the capsule with friction directed from a distal end of a retention strut either anteriorly or posteriorly. Including the additional attributes such as expandability, wedges, barbs, progression blockers, and pins are further refinements of the base concept of transcapsular stabilization for an IOL.

Furthermore, there is no currently available and appropriately sized instrument to allow for the insertion of the novel lens and simultaneous placement. Finally, the approach involves a method for creating a hole or penetration through the capsule of the eye, and there is no specially designed surgical instrument that can make that hole for securing the novel IOL (although a vitrector could feasibly perform this function, it is not designed to do so in a simple and expeditious manner). The approach described includes an instrument, a method with an energy source to create a hole for the second novel lens to attach to the capsule, and also a new novel intraocular lens with a protrusion specifically designed to attach to the capsule of an eye in a new way. Importantly, this approach allows for the proper centration of the second lens in the visual axis. Furthermore, the novel lens may in some embodiments utilize expandable materials such as expandable hydrogels in some or all of the aspects of the design so that once placed, the protrusion will swell, or expand, and create a secure attachment. The small, thin, and partially or dehydrated protrusion can be placed through a small hole with minimal excess force on the original IOL and capsular bag, making the insertion safe, and the expansion thus can atraumatically create a very secure placement. Another important aspect to one embodiment of the technology described herein is the double barrel shape of the lens insertion instrumentation. By having one conduit for fluid, in some embodiments of the present invention, that aspect of the device will allow for a stable anterior chamber and minimize the number of times an instrument must be placed into the eye. For example, in some embodiments a sequence of keratotomy, viscoelastic injection, application of an energy source to create the site for fastening, and then lens inserter placement is not required. In some embodiments of the present invention, one instrument can be inserted for the entire small incision procedure. In other embodiments of the present invention, these steps may vary without detracting from the spirit and broad scope of the present invention.

DISCLOSURE OF THE INVENTION

In accordance with the present invention, there are provided apparati and methods for the treatment of refractive error including ametropia, presbyopia and optical aberrations in an aphakic or pseudophakic eye, comprising an intraocular lens with retention struts that secure an artificial lens inside a patient's eye in a novel manner by engaging a part of the capsule of the eye in a penetrating manner, and a surgical tool for surgical placement of the intraocular lens. The lens has many attributes in different embodiments to help patients see better and to correct vision related problems. Regarding the surgical insertion instrument, the operative head may have a sharp aspect for penetration of the peripheral cornea of the eye; a delivery conduit disposed within said surgical tool for delivery of the secondary intraocular lens with retention strut to the eye, where the distal end of the retention strut is placed into a small hole in the capsule of the eye. The instrument can also allow for passage of a device or instrument that can create a small hole in a capsule. The secondary intraocular lens may comprise a lens affixed to a retention strut; the retention strut having a generally cylindrical form and having a first end and a second end; the first end of the retention structure affixed to the lens and where the second end projects away from the lens. The retention strut is expandable in some embodiments to enhance retention of the lens of the present invention.

The foregoing paragraph has been provided by way of introduction, and is not intended to limit the scope of the invention and its various embodiments described, depicted, or envisioned herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by reference to the following drawings, in which like numerals refer to like elements.

Fig. 1 is a plan view of one embodiment of the novel capsulotomy fixated intraocular lens;

Fig. 2 is a perspective view of the novel lens;

Fig. 3 is a cross section view of the novel lens;

Fig. 4 is a diagram of a natural eye;

Fig. 5 is a diagram of a natural eye with IOL for reference;

Fig. 6 is a close up view of the anterior segment of a natural eye;

Fig. 7 is a front view of a cataractous eye;

Fig. 8 is a front view of an aphakic eye;

Fig. 9 is a front view of a pseudophakic eye;

Fig. 10 is a front view of an aphakic eye with planned small capsulotomy holes for novel IOL stabilization;

Fig. 11 is a front view of a pseudophakic eye with IOL and specially positioned eyelets;

Fig. 12 is a front view of a pseudophakic eye with IOL and specially positioned eyelets, and novel small capsulotomy holes;

Fig. 13 is a front view of an exemplary traditional IOL;

Fig. 14 is a front view of an IOL with specially positioned eyelets;

Fig. 15 is a front view of an embodiment of the novel lens with 105 being of variable length and diameter;

Fig. 16 is a side view of an embodiment of the novel lens;

Fig. 17 is a perspective view of an embodiment of the novel lens;

Fig. 18 is a side view of an embodiment of the novel lens;

Fig. 19 is a perspective view of an embodiment of the novel lens;

Fig. 20 is a side view of the same lens design shown in Fig. 18, juxtaposed with figure 19 for additional clarity;

Fig. 21 is a perspective view of an embodiment of the novel lens with closed loop haptic;

Fig. 22 is a front view of an embodiment of the novel lens with closed loop haptic;

Fig. 23 is a side view of an embodiment of the novel lens with closed loop haptic; Fig. 24 is a perspective view of an. embodiment of the novel lens with closed loop haptic - narrow type configuration;

Fig. 25 is a front view of an embodiment of the novel lens with closed loop haptic - narrow embodiment;

Fig 26. is a side view of an embodiment of the novel lens with closed loop haptic - narrow type configuration;

Fig. 27 is a perspective view of an embodiment of the novel lens with closed loop haptics - double configuration;

Fig. 28 is a front view of an embodiment of the novel lens with closed loop haptics - double configuration;

Fig. 29 is a side view of an embodiment of the novel lens with closed loop haptics - double configuration;

Fig. 30 is a perspective view of an embodiment of the novel lens with a plate haptic - single plate;

Fig. 31 is a front view of an embodiment of the novel lens with a plate haptic - single plate;

Fig. 32 is a side view of an embodiment of the novel lens with single plate haptic.;

Fig. 33 is a perspective view of an embodiment of the novel lens with a footplate type haptic;

Fig. 34 is a front view of an embodiment of the novel lens with a footplate type haptic;

Fig. 35 is a side view of an embodiment of the novel lens with a footplate type haptic;

Fig. 36 is a front view of an embodiment the novel lens with a molded/joined attachment for the haptic 103;

Fig. 37 is a front view of an embodiment the novel lens with two haptics;

Fig. 38 is a front view of the novel lens with two retention struts;

Fig. 39 is a front view of the novel IOL with a lens movement blocker;

Fig. 40 is a front view of a novel IOL with a pointed lens movement blocker;

Fig. 41 is a front view of a novel lens with strut;

Fig. 42 is a cross section view of the lens of Fig. 41;

Fig. 43 is a front view of an embodiment of the novel lens with a protrusion separator;

Fig. 44 is a side cross section view of the lens of Fig. 43;

Fig. 45 is a front view showing the novel lens with two retention struts and a central corrective lens embedded within the optic 101 ;

Fig. 46 is a front view showing the novel lens with one retention strut and one standard haptic and a central corrective lens embedded within the optic 101; Fig. 47 is a front view showing the novel lens with two retention struts and a central corrective lens embedded^■within the optic 101 with toric correction;

Fig. 48 is a front view showing the novel lens with one retention strut, one standard type haptic and a central corrective lens embedded within the optic with toric correction;

Fig. 49 is a front view showing the novel lens with two retention struts and a multifocal lens configuration;

Fig. 50 is a front view showing the novel lens with one retention strut and one standard haptic and a multifocal lens configuration;

Fig. 1 is a front view showing the novel lens with two retention struts and a customized wave front - higher order aberration corrected optic lens configuration;

Fig. 52 is a front view showing the novel lens with one retention strut and one standard haptic and a customized wave front - higher order aberration corrected optic lens configuration;

Fig. 53 is a side view of an embodiment with a haptic angled posteriorly;

Fig. 54 is a side view of an embodiment with a haptic angled anteriorly;

Fig. 55 is a top view of a retention strut's ring piece for attachment to an optic element;

Fig. 56 shows the top view of an embodiment for 109;

Fig. 57 is a side view of a retention strut's ring piece for attachment to an optic element;

Fig. 58 shows a side view of the double ring and strut together;

Fig. 59 shows a side view of the strut 105 alone;

Fig. 60 shows the proximal strut and strut ring combination;

Fig. 61 shows the proximal aspect of the strut in side view with a rounded cap;

Fig. 62 shows the proximal aspect of the strut in side view with a rounded cap and a securing ring;

Fig. 63 shows the proximal aspect of the strut in side view with a flat cap;

Fig. 64 shows the proximal aspect of the strut in side view with a flat cap and a securing ring; Fig. 65 is a top view of the retention strut with the cap and ring system including a bend and wedge;

Fig. 66 is a side view of the retention strut with the cap and ring system including a bend and wedge;

Fig. 67 is a side view of the retention strut with the cap and ring system including a bend, no wedge at distal end of strut;

Fig 68 is an isometric view of the retention strut with the cap and ring system including a bend, wedge at distal end of strut, and a retention securitization disk proximal to the end of the retention strut. Fig. 69 is a side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization disk proximal to end of retention strut;

Fig. 70 is a different side view of the retention strut with ^'the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization disk proximal to the end of the retention strut;

Fig. 71 is a side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization T-piece proximal to end of retention strut; Fig. 72 is a different side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization T-piece;

Fig. 73 is a side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and retention strut securitization barbs proximal to end of retention strut; Fig. 74 is a different side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and retention strut securitization barbs proximal to end of retention strut;

Fig. 75 shows the distal end of the retention strut 105;

Fig. 76. shows the distal end of the retention strut 105;

Fig. 77 shows the distal end of the retention strut 105;

Fig. 78 is a side view of the distal end of the retention strut, no wedge, expansile;

Fig. 79 is a side view of the distal end of the retention strut with wedge, expansile.

Fig. 80 is a side view of the distal end of the retention strut, no wedge, gradient (or variable) expansile;

Fig. 81 is a side view of the distal end of the retention strut, no wedge, gradient (or variable) non-linear expansile;

Fig. 82 shows an embodiment where the optic and haptic associated with the novel lens can be expansile;

Fig. 83 is a side view of the optic 101 with the strut 105 and wedge 107;

Fig. 84 is a perspective view of the double retention strut system with the strut penetrating the optic;

Fig. 85 is a top view of the double retention strut system with the strut penetrating the optic; Fig. 86 is another side view of the optic 101 with the strut 105 and wedge 107;

Fig. 87 is a side view of the optic 101 with the strut 105 and wedge 107;

Fig. 88 is a perspective view of the double retention strut system with the strut emanating from the optic in the plane of the optic; Fig. 89 is a top view of the double retention strut system with the strut leaving the optic in the plane of the optic;

Fig. 90 is another side view of the optic 101 with the strut 105 leaving the optic in the plane of the optic;

Fig. 91 is a side view of the optic 101 with the strut 105 and wedge 107;

Fig. 92 is a perspective view of the double retention strut system with the strut penetrating the optic at an angle;

Fig. 93 is a top view of the double retention strut system with the strut penetrating the optic at an angle;

Fig. 94 is another side view of the optic 101 with the strut 105 exiting the optic at an angle with wedge 107;

Fig. 95 is a side view of the optic 101 with the strut 105 and wedge 107;

Fig. 96 is a top view of the double retention strut system with the strut including a bend;

Fig. 97 is another side view of the optic 101 with the strut 105 exiting the optic with associated bend 301 ;

Fig. 99 is a front view of an exemplary traditional IOL;

Fig. 100 is a front view of an IOL with specially positioned eyelets;

Fig. 101 is a top view of a double strutted novel IOL in place with primary IOL with eyelets inside the eye;

Fig. 102 is a top view of a single strutted novel IOL with one standard haptic in place with primary IOL with eyelets inside the eye;

Fig. 103 is a top view of a single strutted novel IOL with one standard haptic in place with a primary IOL without eyelets inside the eye;

Fig. 104 is a top view of a double strutted novel IOL in place with a primary IOL without eyelets inside the eye;

Fig. 105 is a side view of a novel IOL with two retention struts pointing posteriorly and engaging in a stable secured manner the primary IOL which is in the capsular bag;

Fig. 106 is a side view of a novel IOL with one standard haptic engaging the ciliary sulcus and one retention strut pointing posteriorly and engaging in a stable secured manner the primary IOL which is in the capsular bag;

Fig. 107 is a cross section of an eye with a primary IOL in the capsular bag, and a secondary novel lens in place.

Fig. 108 is a cross section of the eye with a higher magnified view, anterior segment of the eye; Fig. 109 is a cross section of an aphakic eye, with the novel lens with two retention struts emanating at an angle, piercing anterior and posterior leaflets of the capsule;

Fig. 110 is a cross section of the eye with a primary IOL in the bag, and the secondary novel lens in place;

Fig. 1 11 is a cross section of the eye with a primary IOL in the bag, and a secondary novel lens in place;

Fig. 112 is a cross section of an aphakic eye, with the novel lens with one retention strut;

piercing the anterior and posterior leaflets of the capsule and one standard haptic;

Fig. 113 is a side view of a double barreled insertion instrument;

Fig. 114is a cross section of the insertion instrument;

Fig. 115 shows a side view of the proximal operative end of the surgical instrument;

Fig. 116 depicts a side view, cross section of the double barrel proximal end of the instrument;

Fig. 117 is a side view, cross section of a triple barrel proximal end of the instrument;

Fig. 118 is a side view, cross section of the triple barrel instrument with a view of the middle section;

Fig. 119 is a side view of the surgical instrument;

Fig. 120 depicts a cross section of one embodiment of the surgical instrument;

Fig. 121 shows the tip of the instrument in a rounded embodiment;

Fig. 122 is a plan view of the double barrel embodiment with a folded IOL in the larger passageway of the instrument;

Fig. 123 is a plan view of the double barrel embodiment with a folded IOL in the larger passageway of the instrument;

Fig. 124 is a plan view of the double barrel embodiment with the folded IOL exiting the larger passageway of the instrument;

Fig. 125 is a plan view of the double barrel embodiment with the folded IOL exiting the larger passageway of the instrument.

Fig. 126 is a plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument;

Fig. 127 is a plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument and advancing;

Fig. 128 is a plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument and the micro forceps now open inside the eye;

Fig. 129 is a plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument and the micro forceps open inside the eye; Fig. 130 is a perspective view of another embodiment of the insertion instrument;

Fig. 131 is a side view of another embodiment of the insertion instrument;

Fig. 132 depicts a cross section of the instrument of Fig. 131;

Fig. 133 is a side view of the instrument with the wider proximal end providing a lens folder; Fig. 134 is a top view of the instrument (when the instrument is placed on a flat horizontal surface with the proximal end inferiorly) for IOL insertion with the wider proximal aspect for lens insertion and folding;

Fig. 135 is a bottom view of the instrument (when the instrument is placed on a flat horizontal surface with the proximal end inferiorly) for IOL insertion with the wider proximal aspect for lens insertion and folding;

Fig. 136 is a cross section of the embodiment of the instrument for IOL insertion and infusion with the wider proximal aspect for lens insertion and folding;

Fig. 137 is a side view of the distal aspect of the plunger;

Fig. 138 is a perspective view of the distal aspect of an embodiment of the plunger or lens guiding device;

Fig. 139 is a cross section view of the distal aspect of an embodiment of the plunger or lens guiding device;

Fig. 140 is an alternative embodiment of the plunger / IOL guide;

Fig. 141 is a side view of the distal end of the micro- forceps of the present invention;

Fig. 142 is a perspective view of the distal end of the micro-forceps;

Fig. 143 is a cross section of the device depicted in Fig. 141 ;

Fig. 144 is a side view of the distal end of the micro-forceps;

Fig. 145 is a perspective view of the distal end of the micro-forceps;

Fig. 146 is a cross section view of the device shown in Fig. 141;

Fig. 147 is a side view of the device used through the insertion instrument to create the small capsulotomy for the retention strut to engage the capsule in a penetrating manner;

Fig. 148 is a side view of the device used through the insertion instrument to advance and/or manipulate the IOL of the present invention;

Fig. 149 is a front view of an eye with a decentered primary IOL and a well-centered secondary IOL with retention strut of the present invention;

Fig. 150 is a cross section view of the anterior segment of the eye with a decentered primary IOL and well-centered secondary IOL with retention strut of the present invention;

Fig. 151 shows a cross section of the eye with the insertion instrument in the eye; Fig. 152 depicts a front plan view of an embodiment of the novel IOL with retention struts and an opaque ring around the center of the optic ;

Fig. 153 depicts an embodiment of the intraocular lens with a single haptic, the optic and retention strut projecting anteriorly; and

Fig. 154 depicts the embodiment shown in Fig. 153 inside the eye. The intraocular lens is a primary IOL in this embodiment, and is placed in the capsular bag. There is one haptic and one retention strut.

The present invention will be described in connection with a preferred embodiment, however, it will be understood that there is no intent to limit the invention to the embodiment described. On the contrary, the intent is to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by this specification, claims and the attached drawings.

BEST MODE FOR CARRYING OUT THE INVENTION

For a general understanding of the present invention and the various embodiments described and envisioned herein, reference is made to the drawings. In the drawings, like reference numerals have been used throughout to designate identical elements.

For reference, the following table is provided as a guide to the figures, and greater detailed descriptions are provided following the table.

101 Optic of novel lens

103 haptic

105 Retention strut

107 Wedge

107 Wedge attachment

109 Attachment system for retention strut at proximal

end of strut near optic

1 11 Progression blocker

1 13 Open loop haptics

301 Strut with bend allowing for redirection of leading

edge from optic strut capture site - bend is posterior

to optic

400 Eye

401 Cornea

403 Conjunctiva

405 Anterior chamber of anterior segment

407 Iris

409 Sclera

411 Human lens

413 Zonules

415 Vitreous, vitreous gel

417 Medial rectus extra ocular muscle

419 Retina

421 Optic nerve

423 Anterior capsule

443 Lateral rectus extra ocular muscle

425 Posterior capsule

427 Ciliary body

429 Choroid

431 Ciliary sulcus

433 Pupil

435 Optic nerve sheath 437 Optic disc

439 Pars plana

441 Corneoscleral junction

501 Primary intraocular lens

503 Capsulorhexis

505 Primary intraocular lens optic

601 Lens Capsule recess

701 Cataract

703 Equator of capsule - insertion point for zonules.

801 Aphakia

1001 Small capsulotomy holes (novel)

1101 Primary IOL with specially positioned eyelets

1103 Eyelets

1105 Haptic with eyelet

1201 Alignment of capsulotomy holes over primary lens eyelet

1801 Strut with bend allowing for redirection of leading edge from optic strut capture site - bend is anterior to optic

2100 Novel lens example with one strut and one wide closed loop haptic

2101 Closed loop haptics

2401 Narrow closed loop haptic

2403 Novel lens example with one strut and one open loop haptic

2400 Novel lens example with one strut and one narrow closed loop haptic

2700 Novel lens example with one strut and two (double) closed loop haptics

2701 Closed double V loop haptic

2703 V loop haptic with acute angle at distal end

3101 Plate haptic

3301 Footplate

3303 S-curve type double loop haptic

3601 Example of longer retention strut 105

3603 Insertion of haptic into optic for as t-type approach to two part optic haptic configuration.

3700 Example of double haptic, double retention strut configuration

3801 Double retention strut system

3901 Lens movement blocker

4001 Pointed lens movement blocker

4101 Curved ridge lens separator 4201 Meniscus lens

4301 Protrusion separator

4501 Novel lens with central presbyopic correction

power in optic

4503 Two retention struts in one novel lens

4505 Optic power independent of central correction lens base power

4601 One retention strut and one haptic in novel lens

4701 Novel lens with cylindrical / toric correction

4901 Multifocal correction optic

5101 Wavefront correction in lens

5301 Haptic s form an angle theta with the optic in the anterior-posterior direction plane

5303 Retention strut projects in same plane as optic

5401 Haptic s form an angle negative theta with the optic in the anterior-posterior direction plane

5501 Ring to cylinder fixation for strut to optic

5503 Inner diameter of ring fixation system, can also show protrusion of strut through 5501

5601 Ring structure that surround strut to enhance strut optic attachment

5603 Internal opening in ring cap for strut 105

5701 Inner ring in ring fixation system that interacts with hole in optic

6001 Partial drawing; distal end of strut not shown

6101 Rounded cap of anterior end of retention strut

6301 Flat cap of anterior end of retention strut

6601 Thinner ring like components 5601

6701 Distal end of strut, multiple shapes in different embodiments

6801 Retention securitization disk for optic end of

retention strut

6801 Progression blocking ring for distal end of retention strut

7101 Progression blocking T for distal end of retention strut

7301 Progression blocking "fork" or "barb" for distal end of retention strut

7501 Capsule capture "barb" for securitization to bag to prevent migration in direction of optic

7601 Capsule capture "double barb" for securitization to bag to prevent migration in direction of optic 7701 Capsule capture "open loop" flap for securitization to bag to prevent migration in direction of optic

7801 Uniform expansion of any design of retention stmt non expanded

7803 Uniform expansion of any design of retention strut expanded

7901 Uniform expansion of retention strut with non

expanded with accessories

7903 Uniform expansion of retention strut with

accessories - expanded

8001 Variable but linear expansion gradient non

expanded strut

8003 Variable but linear expansion gradient, proximal end expands less than proximal optic end of retention strut

8005 Variable but linear expansion gradient, distal end expands significantly more than proximal optic end of retention strut

8101 Variable nonlinear expansion gradient non

expanded strut

8103 Variable nonlinear expansion gradient, proximal end expands less than proximal optic end of retention strut

8105 Variable nonlinear expansion gradient, distal end expands significantly more than proximal optic end of retention strut

8201 Expandable optic and haptic non- expanded

8203 Expandable optic and haptic expanded

8301 Retention strut may engage optic through hole in lens optic

8801 Retention strut emanates in plane of optic

9101 Retention strut may engages optic through angled hole in lens and exits in posterior and outward direction

9201 Radius of perimeter of lens design

10101 Secondary novel IOL in position with struts in eyelets positioned over primary IOL with eyelets; two struts shown

10201 Secondary novel IOL in position with strut in eyelet positioned over primary IOL with eyelets; one strut, one standard haptic shown

10201 Novel secondary IOL optic is smaller than primary IOL optic

10301 Novel secondary IOL optic is larger than primary IOL optic 10303 Secondary novel IOL in position with one strut and one standard haptic positioned over primary IOL without eyelets; capsular bag not shown

10401 Secondary novel IOL in position with two struts positioned over primary IOL without eyelets; capsular bag not shown

10500 Novel and primary IOL in position piggyback; two struts

10600 Novel and primary IOL in position piggyback; one strut and one haptic

10701 Novel and primary IOL in position piggyback; two struts- shown in eye

10901 Novel IOL in position in aphakic eye, two struts -- shown in eye

1 1101 Novel and primary IOL in position piggyback; one strut and one haptic- -in eye

1 1301 Infusion connector

1 1303 Infusion passageway distal exit from instrument

1 1305 Insertion instrument shaft - external surface

1 1307 Insertion instrument distal end

1 1309 Insertion instrument proximal end

1 1300 Insertion instrument

1 1401 Internal aspect of lens insertion passageway

1 1403 Passageway for IOL distal opening in instrument

1 1405 Proximal opening of large passageway in

instrument

1 1407 Internal passageway of narrow cannula of

instrument

1 1501 Proximal aspect of instrument generally

1 1503 Distal aspect of instrument is not shown

1 1505 Small conduit that connects a line to a larger

internal bore opening in the instrument

1 1601 Internal non-passageway space in instrument

1 1701 Third internal passageway

1 1801 Proximal aspect of instrument (operative end) not shown

1 1901 Sharp pointed tip of instrument

1 1903 Larger lumen or passageway opening at distal end of instrument

1 1905 Smaller lumen opening for infusion at distal end of instrument

12101 Rounded leading edge of instrument

12201 Novel IOL folded inside instrument

12203 Distal aspect of device to advance IOL through lumen

12205 Shaft of advancement instrument

12301 Novel IOL folded inside instrument, now exiting instrument

12207 Indicator of bevel aspect of distal end of insertion instrument

12501 Novel IOL almost completely out of instrument, starting to unfold

12601 Novel IOL unfolded outside insertion instrument

12801 Microforceps / jaws of advancement device

13001 Housing of IOL folding aspect of instrument

13003 Finger grips for insertion instrument

13201 Widest aspect of internal bore for lens passage

13401 Distal aspect of instrument

13501 View of opening inside insertion lumen

13601 Novel IOL being folded inside wide passageway

13701 Distal aspect of plunger / IOL advancement device

13703 Proximal aspect of device not shown

13901 Internal cup of advancement tool

14001 Rounded distal tip of advancement tool

14301 Internal structure of advancement tool

14401 Two jaw micro-forceps

14701 Body of small capsulotomy tool

14703 Tip of small capsulotomy tool

14801 Distal tip of hook or pick tool

14803 Next most distal section of pick or hook

14805 Transition from hook or tip to body of tool

14807 Bend in mid section of hook or pick

14809 Bend from distal tip of hook to next most distal section

14811 More proximal aspect of hook or pick instrument

14813 Shaft of instrument

14901 Decentered primary IOL

14903 Well centered novel IOL

15001 Visual axis

15003 Primary IOL axis not in visual axis of eye

15101 Insertion instrument inside eye

15201 Central clear opening in modified version of novel IOL

15203 External opaque ring on novel IOL

15301 Retention strut projecting first outwardly,

containing a bend, and projecting the distal end anteriorly for engagement with anterior capsule. The present invention and the various embodiments described or suggested herein rely on a surgical technique where a small hole is made in the capsule and the novel intraocular lens with retention struts is installed in the eye by piercing the capsule with the retention strut and the novel lens is thus mechanically retained therefore improving vision.

The lenses, apparati and methods of the present invention are critically important as an approach to pseudopha c presbyopia and pseudophakic or aphakic ametropia. The apparatus and method of the present invention may be critically important as an approach to situations where a premium IOL or single power standard IOL have created a refractive error that is unsatisfactory for a patient.

Incorporated by reference herein in its entirety is United States Patent Application 61/819,636 entitled "Apparatus And Method For The Treatment of Presbyopia In a Pseudophakic Eye" by Dr. David M. Kleinman.

Turning now to the drawings, both exemplary lenses and surgical devices, as well as related devices and methods, will be described using the drawings attached herein.

Fig 1. is a plan view of one embodiment of the novel capsulotomy fixated intraocular lens This novel IOL has several advantages over current IOL designs in that, to name a few, it is stabilized with a novel retention strut, it can be precisely placed and oriented inside the eye, and it can provide a suitable alternative to planned premium IOL, multifocal IOL, or accommodating IOL surgery. Additionally, in some embodiments it is delivered to the eye through a small incision in keeping with advancing small incision eye surgery technology. This novel IOL is foldable or Tollable, or compressible in a manner so that it is delivered through a small incision and through a device that enters the eye through an incision in the sclera or cornea.

101 Optic of novel IOL. Embodiments include properties of any varieties of power correction including negative and positive diopters. Embodiments include cylindrical correction or toricity. Embodiments include a multifocal component. Embodiments include a blue blocking filter. Embodiments include a concentric power configuration. Embodiments correct for presbyopia. Embodiments provide wave front or customized correction. Embodiments are convex or concave. Embodiments have a lens power of any known combination of spherical and cylindrical power, as well as presbyopic and customized correction. Expected range is between -20 diopters and + 20 diopters. Any feasible cylindrical correction is included. Lens configuration is biconvex, piano convex, positive meniscus, negative meniscus, piano concave, biconcave. Any material for the lens suitable for an ocular implant is acceptable, including acrylics, transparent polymers and silicone lenses, hydrophilic, and expandable hydrophilic designs are contained in the embodiment.

The optic is the part of the structure and device that provides vision improvement or refractive correction. In some embodiments it is utilized for cosmetic correction for aniridia or iris structure abnormalities whereby the pupil is excessively large, misshapen, or irregular.

The vision correction or refractive correction aspect includes an optic that can correct any of the following concerns, abnormalities, findings, or symptoms: presbyopia (with an inner concentric correction designed to allow the patient to read and view objects at near -possibly through a more miotic pupil more clearly), simple spherical correction (for example, when a primary implanted IOL imparts a refractive error to the eye which causes pseudopha c hyperopia or myopia. Furthermore, the patient has had a premium IOL placed, either an accommodating or multifocal IOL meant to provide the patient with a level of vision such that spectacle correction is not required for distance or near. If such a premium IOL is not piano at distance, the patient's subjective impression of vision quality at distance and near without correction is negatively impacted. Thus, a power of the optic is selected for optimal correction. There is also a need to correct for astigmatism, thus the optic has, in some embodiments, cylindrical correction or toricity. Presbyopic correction in the form of a small central positive corrective lens is included. Multifocal or concentric lens design is one embodiment. Wavefront or customized, higher order corrections are allowed- coma, spherical aberration, quadrafoil, trefoil, secondary coma, tip tilt correction, defocus, and secondary astigmatism. Use of this lens allows for an eye with cancelled, minimal or no optical aberration. Thus, this invention allows for complete or partial correction of refractive errors in an aphakic eye, or enhanced correction in a pseudophakic eye.

An irregular or large iris is not infrequently associated with image glare or other visual complaints including monocular diplopia that the presented device can address because of its ability to be precisely fixated in the center of the visual axis. A cosmetic problem is associated with a large or irregular iris. Iris related glare can also be bothersome to a patient with a large pupil. These and other symptoms can be corrected with the creation of a smaller more normal shape of the pupil. In this embodiment there is an inner clear circle (inner concentric) and an outer concentric shape that is darkened brown, blue, or another color to match the subject iris or to correct for iris related cosmetic or visual glare problems. Carbon black or other stable pigments safe for implants may also be used with the iris replacement design.

103 Haptic of novel IOL. Embodiments of the novel IOL have one or two, or more haptics that stabilize the IOL by interacting with the ciliary sulcus or recess of the capsular bag. These haptics help stabilize the IOL in the posterior chamber of the anteri or segment of the eye. The haptic is in one embodiment on the opposite edge of the novel retention strut that is also part of this lens device. The haptic is open loop, J -- loop, C-Loop, open loop with footplates akin to some anterior chamber IOL designs, plate type, closed loop haptics (C or V, narrow or wide). The haptic rests in the sulcus, or possibly in the bag or in the anterior chamber. The haptic is molded, or attached as in a two piece, or three piece design. The optic is one piece, and each haptic is be considered another piece. The haptic is the same piece as the optic. The material for the haptic is PMMA, acrylic, silicone, any variety of polymers that can be used for haptics on IOL's currently in use. The material is expandable hydrophilic. The length of these haptics is of a value that fits in the anterior segment of the eye and enhances IOL stabilization. The length is between 4 mm and 10 mm in some embodiments, and can be measured in several ways. In one method for measuring the length of the haptic, the actual length of the haptic itself is measured, following the curve, or looping back for example. In other methods of measuring, the distance is measured in a way that quantifies the point farthest from the edge of the optic, in a direct line. The length of the haptic (or each haptic) may be between 3 mm and 30 mm. The preferred length in some examples is between 6 mm and 20 mm. The absolute distance the haptic extends away from the optic at rest outside the eye in a flat state may be measured and can range typically between 3mm and 1 1 mm.

105 novel retention strut. This novel retention strut is utilized to secure the IOL in the eye by penetrating into, possibly through the capsular bag from an anterior to posterior or posterior to anterior location. The strut is designed specifically to attach to the lens and point outward. There may be a bend in the retention strut redirecting the distal end either anteriorly or posteriorly. The retention strut may project outwardly, but also at angle off the horizontal plane with the optic. Outward or outwardly, in some embodiments, refers to the retention strut or other structure projecting away from the lens in any direction. For sake of clarity, any direction includes, but is not limited to, having an aspect that projects anteriorly, radially, or posteriorly, at least in part. The outward end will engage the capsular bag. Whereas a typical haptic secures the IOL by putting pressure inward toward the optic from either the recesses of the capsular bag or sulcus, in other words, from the outer aspects of a loop or plate haptic, thereby securing the IOL in place, this novel retention strut secures the IOL in place by attaching the IOL directly to the anterior and/or posterior leaflets of the capsule, or penetrating through the anterior or posterior leaflets of the capsule, or in some embodiments, penetrating or engaging both. The engagement, if not penetration through, can be frictional and is in a direction off the plane of horizontal with the optic. Sometimes the anterior leaflet is recessed or torn or missing so that the attachment will go from an anterior location through the posterior capsule only. Sometimes the posterior capsule is torn or recessed or otherwise missing and the strut will penetrate from an anterior to posterior direction the anterior capsule only. In some embodiments the lens will be placed in the capsular bag and the retention strut will project outwardly then bend to project anteriorly for engagement and/or penetration of the anterior capsule only. In some embodiments, for example when the novel lens is placed in the sulcus anterior to the anterior capsular plane, the leaflets are directly opposed or both intact and close together, the strut will penetrate both leaflets of the capsule and through its attachment to the IOL optic will secure the lens in place. If there is only one strut, there is in some embodiments the potential for the optic to rotate clockwise or counter clockwise about the strut at its insertion into the capsular bag. Hence, in some embodiments there is a standard haptic on the other diametric of the optic. The strut in some embodiments can be made of an expandable hydrogel allowing for a stiffness of the strut for placement, and secondary expansion to secure the optic by f iction within the capsule. The strut is be made of PMMA or other acrylic, silicones, or polymers. The strut is be made of biocompatible metals including titanium and nitmol. The retention strut has attachments or characteristics to help improve its performance in stabilizing the IOL. The IOL has more than one retention strut in some embodiments. The strut is, in some embodiments of the present invention, round, oval, square, rectangular, triangular, oblong, or other shapes in the cross-section, depending on the embodiment. The strut is cylindrical in one embodiment. The strut is of a length suitable to accomplish the task of securing the optic to the capsule. The length is to be between 1 mm and 8 mm, but more likely is between 2 mm and 5 mm in length. The diameter of the strut is between 0. 1 mm and 3 mm but more likely is between 0.3 mm and 2 mm in diameter in cross section of the body of the strut. The retention strut has a single or double taper in some embodiments. The diameter is thus variable in some embodiments. Furthermore, in some embodiments, this novel IOL makes use of expandable polymer technology to enhance stabilization and ease of placement. For example, the strut may be structurally less mobile and deformable (more rigid) in a less hydrated state for placement, and once in the eye the strut swells securing the interaction with the capsule and further securing the lens in position. The strut and novel IOL is compatible with a capsular tension ring. The retention strut may engage an eyelet in a capsular tension ring in some embodiments of the device.

107 wedge strut tip. The distal end of the strut has a shape that enhances capture and stabilization of the IOL in the eye. A wedge design or cone tip is be used in some embodiments to help secure the strut to the capsular bag when it crosses from anterior to posterior. Such a wedge fit tip will prevent migration of the lens in the direction away from the strut itself, and can have utility in preventing a slippage from the strut out of the capsule. The wedge has utility in enhancing stabilization of the IOL. The wedge strut tip is be made of any biocompatible material but in particular is be made of an expandable hydrogel which allows for additional size based stabilization. Thus the wedge penetrates easily or with minimal force through the opening in the capsule (specific capsulotomy), and then expands while in the eye (which is aqueous internally) to further prevent movement in a direction toward or away from the strut/optic connection. The strut is be connected to the optic by molding (there is to be a gradient of expandability in the strut), or the strut is be a separate piece akin to a three piece lens construction.

109 Attachment system for retention strut. As mentioned, the strut is molded from the same material as the optic, in which case the attachment is more theoretical than visible. However, in some embodiments of the present invention, the strut is manufactured separately or in different stages as the optic before they are put together in later manufacturing steps. In such an embodiment, there will be a multi-piece system. The optic is molded around the proximal tip of the strut, or the optic has a hole left in it, and the strut is secondarily attached. This hole in the optic is not visible in the drawings because the retention strut with attachment system is shown in place. The hole in the optic does not need to be round. It is square or rectangular in some embodiments. The hole may be alternative shapes in other embodiments of the present invention. The shape choice is determined in part so that rotation of the retention strut in the hole in the optic is minimized. This second step is to be indicated if the expansile differences between the optic and the strut make molding around the strut's distal end less optimal. Thus the strut, with a circular or enlarged diameter tip is to be placed through the hole in the IOL in one manufacturing process thereby securing it to the optic and allowing for an expansion of the strut in a way that will not negatively affect the junction of IOL and strut. The attachment system for the retention strut is a snap fit mechanism.

11 1 Progression blocker. This functional shaped structure is a protrusion on the strut itself, proximal to the distal end. Its role is to prevent migration or movement of the optic in the direction of the strut to allow for controlled and optimally placed fixation. Its location at some distance between the optic and the distal end of the strut will prevent movement by engaging the capsule and blocking progression. There are several embodiments that fulfill the requirement of this aspect of the novel lens.

113 The haptic 103 in this embodiment is a standard open loop, or J-loop type haptic. Other configurations of the haptic, or the J loop type are encompassed as a haptic in the various embodiments of the invention. There is a horizontal plane stabilizing haptic, and a strut (105) that projects outward from the optic and engages the IOL, anterior lens capsule, posterior lens capsule, or both leaflets. A hole (or small round capsulotomy) is placed either during the procedure with heat, laser, sharp instruments, ultrasound, or other mechanical methods. The hole (small round capsulotomy) is made with an external laser such as a femtosecond laser in some embodiments of the methods of use of this novel lens.

Fig. 2 is a perspective view of novel lens and Fig. 3 is a cross section view of the novel lens.

310 there is a bend in the retention strut as shown in figure 3. This bend allows for attachment to the optic of the strut, and then allows for a directionality of the strut toward the plane of the optic as opposed to at a right angle to it. The angle is anywhere between 1 degree and 100 degrees when compared to the line of the strut through the optic. In other words, a 90 degree bend would put the strut pointing in the direction of the optic's leading edge (leading with strut). The bend has any of the following: sharp curve, right angles, gentle bends, and multiple bends.

Fig. 4. 400 Eye Diagram with natural lens for reference, cross section of eye, horizontal plane, mid-way positioned.

401 Cornea. Transparent anterior outer wall of eye. Incision through cornea allows for instrument access to anterior chamber.

403 Conjunctiva. Outer lining mucous membrane over sclera.

405 Anterior chamber. 3.5 mm deep. An instrument can be placed in the anterior chamber for surgical manipulation of an IOL.

407 Iris. The iris is the colored part of the eye visible through the cornea. The opening creates the pupil which is typically round but can be irregular. An IOL can sit in front of or posterior to the iris. The iris can be treated with medications to dilate the pupil.

409 Sclera. The white, tough, structural wall of the eye. Where there is no cornea, there is sclera to form the eye ball.

41 1 Human lens. Composed of cortical and nuclear lens material. Situated in the posterior chamber of the anterior segment. When the transparency changes (decreases), the lens can be called a cataract. The lens sits in the capsule, which has anterior and posterior leaflets. In typical cataract surgery, the lens is removed from the supporting capsule. A space is created for placement of an in-the-bag positioned IOL. 413 Zonules. Support the lens, holding it in position. Fibers attach from the equatorial capsule to the ciliary processes and hold the lens in position. The Zonules can tear during cataract surgery decreasing sta bility of the IOL placed in^' the bag or sulcus.

415 Vitreous. The vitreous is a water based structure composed of water (99%), salts (0.9%) and collagen and proteoglycans, and hyaluronic acid (<1%). These components give the vitreous a gel like characteristic. The vitreous makes up the majority of the posterior segment based on weight and volume. There are about 3.5 cc in the adult vitreous. The vitreous can remain intact after cataract surgery, or sometimes migrate anteriorly into the anterior segment, and make cataract surgery more challenging.

417 Medial rectus muscle. One of six extraocular muscles of the eye. Controlled by the cranial nerve III to move the eye medially.

419 Retina. The light sensing portion of the back of the eye. Light is converted by the retna into a neurologic signal that travels from retina to ganglion cells through the optic nerve. Light is focused by the cornea and lens onto the retina. The retinal image has aberrations that limit the image quality on the retina. Aberrations include myopia (positive defocus), hyperopia (negative defocus), regular astigmatism, prisms and piston. Other aberrations include spherical aberration, coma and trefoil. There are other aberrations as well. The retina is critical to sight. The quality of the image is dependent on the optical characteristics of the entire eye.

421 Optic nerve. The optic nerve leaves the posterior segment through the optic disc carrying neurologic impulses conveying retinal perception to the brain.

423 Anterior capsule. The anterior capsule is the front part of the lens capsule that contains the lens of the eye. In order to perform modern cataract surgery from an anterior approach (cornea or anterior sclera) there must be some form of incision of the anterior capsule to allow access of surgical instruments to the lens. Typically the incision is with a needle and the capsule is torn in a circumferential or curvilinear pattern to open the anterior capsule and the small remnant of the anterior capsule is removed with forceps. The capsular rhexis can also be made with a femtosecond laser. The capsule can be cut repeatedly with a small bent needle to similarly open the capsule. Other techniques for accessing the lens through the anterior capsule exist. The anterior capsule is approximately 10 to 15 microns thick.

425 Posterior capsule of the eye. Very thin aspect of the capsule that surrounds the lens of the eye.

443 Lateral rectus muscle. One of six extraocular muscles of the eye. Controlled by the cranial nerve VI to move the eye laterally. 427 Ciliary Body. Insertion of the zonul es into the ciliary processes which is part of the ciliary body. The ciliary body produces fluid to keep the eye pressurized. Fluid egresses through the trabecular meshwork of the angle or by uveoscleral outflow.

429 Choroid. Vast network of blood vessels that provide nutrients to the retina. Middle layer of the eye wall, sandwiched between the retina and sclera. Less than 1 mm thick. Connected to ciliary body and iris. Uveal tissue.

431 ciliary sulcus. This space is anterior to the zonules and anterior lens capsule. As long as there is some zonular tissue, the sulcus can provide support for an IOL, typically through a traditional open loop or plate haptic.

433 Pupil. The passage for light into the eye. The pupil depicted is dilated. The pupil can be any size between 1mm and 8 or greater mm. The pupil can be round or irregular. Ideally the center of the pupil aligns with the visual axis of the eye.

435 Optic nerve sheath. Connective tissue surrounding optic nerve as it exits the eye.

437 Optic disc. The optic nerve head visible during examination of the posterior segment of the eye.

439 Pars plana. Area on the eye posterior to the scleral corneal junction where there is no retina or ciliary body directly posterior to the sclera. Uveal tissue is present. A site for surgical access to the vitreous.

441. Cornea scleral junction. The transition from clear cornea to the white sclera. Parts of this junction are often visible normally when the eye is open.

Fig. 5. Eye Diagram with IOL for reference, cross section of eye, horizontal plane, midway positioned.

501. Traditional or Premium primary intraocular lens (IOL). The IOL here is positioned in the capsular bag. This lens is primary, placed first, already in position. The natural lens or cataract has been removed. The haptics extend into the recesses of the capsular bag for fixation.

503. Edge of capsulorhexis. The anterior capsule can be surgically manipulated to create an opening for access to the lens and to place an IOL. The capsule can be manipulated by needle, blade, or laser. The anterior and posterior edges of the capsule can rest in contact or near contact after the relatively thick lens is replaced with a thin IOL.

Fig. 6. Close up view of anterior segment.

601 Capsular bag recess where haptic of IOL rests. Similarly, a capsular tension ring is to be placed in the recess of the capsular bag. A capsular tension ring, not shown, expands into the capsular bag space to help stabilize the capsule. The novel IOL can interact with eyelets in a capsular tension ring, or simply interact with a capsule stabilized by the capsular tension ring. 603 haptic of IOL.

Fig. 7. 700 Front view of cataractous eye.

701 Cataract. Here ^'the lens of the eye is hash marked as an example of a cataractous lens.

703 equator of lens, where zonules insert (not visible from this view, behind iris).

Fig. 8. Front view of aphakic eye.

801 Aphakia. Empty capsule, no lens, no IOL.

Fig. 9. Front view of pseudophakic eye.

Fig. 10. Front view of aphakic eye with planned small capsulotomy holes for novel IOL stabilization.

1001 small capsulotomy holes made in capsule. Can be made through both anterior and posterior leaflets of the capsule. Can also be made through just the anterior or just the posterior leaflet. This surgical decision as to whether the small capsulotomy is made in both anterior and posterior capsule membranes, or just the anterior capsule leaflet or just the posterior capsular leaflet will depend on the intended location of the new IOL, as well as the relative presence of anterior and posterior capsules. Sometimes the posterior capsule is missing because of rupture at surgery or because of a secondary YAG posterior capsulotomy. The anterior capsule can be off center with regard to the rhexis. The anterior capsule can also tear during cataract surgery. Thus, the positioning holes for the novel IOL and strut is through both anterior and posterior capsule or one or the other. These holes are made in an aphakic or pseudophakic eye and allow for stabilization of the novel strut based IOL in the eye.

Fig. 11. Front view of pseudophakic eye, IOL with specially positioned eyelets.

1101 IOL with specially positioned eyelets. These eyelets are located at the optic/haptic junction for primary IOLs. The eyelets allow for very precise coaptation of the novel lens with the retention strut to the primary lens. The retention strut (or struts) are placed through the eyelets. The secondary, novel lens with the retention strut will be stabilized in front of the primary IOL once positioned.

1103 Eyelets.

1105 Haptic for IOL with specially positioned eyelets. Haptics and eyelets are in one embodiment of the same molded material.

Fig. 12. Front view of pseudophakic eye, IOL with specially positioned eyelets, and novel small capsulotomy holes

1201 Showing the placement of the novel capsulotomy holes in alignment with the eyelets of the primary IOL shown in 1 100. The primary IOL is sitting between the anterior and posterior capsules, in-the-bag. The primary IOL, in some cases, also resides in the sulcus. Either way, the eyelets and small capsulotomy holes can be aligned to allow for very close localization of the secondary novel strut based IOL to the primary IOL. The placement location can be predetermined to optimize optics, such as for toric, presbyopic or wave front correction.

Fig. 13. Front view of exemplary traditional IOL.

Fig. 14. Front view of IOL with specially positioned eyelets

Fig. 15. Front view of an embodiment of the novel lens. Note 105 is of variable length and diameter. Likewise the optic is of variable thickness and diameter. Haptic 103 is representative in terms of shape and size. This haptic is designed for location in the sulcus or capsule. Sulcus is preferred in one embodiment. Material may include silicones, acrylics, PMMA, and hydrophilic polymers that expand with hydration.

Fig. 16. Side view of an embodiment of the novel lens. In this image the bend 301 is shown closer to the posterior aspect of the lens.

Fig. 17. Perspective view of an embodiment of the novel lens. Note 105 is of variable length and diameter. Likewise the optic is of variable thickness and diameter. Haptic 103 is representative in terms of shape and size. This haptic is designed for location in the sulcus or capsule. Sulcus is preferred in one embodiment. Material is any listed in specifications and include silicones, acrylics, PMMA, and hydrophilic polymers that expand with hydration.

Fig. 18. Side view of an embodiment of the novel lens. Note 105 is of variable length and diameter. Likewise the optic is of variable thickness and diameter. Haptic 103 is representative in terms of shape and size. This haptic is designed for location in the sulcus or capsule. Sulcus is preferred in one embodiment. In this embodiment, the bend 301 is closer to the anterior surface of the lens. The bend is labeled here as 1801. If the attachment system were shown such as 109 in Fig. 16 exemplifies, it may be on the posterior surface. In other words, a bend in the retention strut 105 can be anterior to the lens or optic, posterior to the lens or optic, or can have a double bend, not shown. The bend can be of any degree between 1 and 90 degrees, but in one preferred embodiment, the bend is between 15 and 75 degrees, or between 30 and 60 degrees. The bend allows for a more vertical connection to the optic 101 where the angle of the strut can point away from the lens, but also generally posteriorly so the strut may interact with the anterior and or posterior leaflets with the capsule or an eyelet on a primary IOL. The bend can be in the anterior posterior direction, or have a side to side component, as well. Material may include silicones, acrylics, PMMA, and hydrophilic polymers that expand with hydration. Fig. 19. Perspective view of an embodiment of the novel lens. 1801 shows the bend on the anterior aspect of the lens device, or optic 101. The Strut 105 is leaving the optic from the anterior surface, and then it bends so that the strut can be positioned to engage the capsule which will be in a posterior direction.

Fig. 20. Side view of the same lens design shown in Fig 18, juxtaposed to figure 19 for additional clarity. But again, all configuration of designs and parts can be grouped and regrouped in many ways and remain embodiments of the current intraocular lens with retention struts. Here, for example, the haptic 103 can be considered to be any type of standard haptic as described in this application. Haptics include Open loop and closed loop designs, J loop, C- loop, and multiple loop designs. Foot plates may be used in the haptic. The haptic may project at any of several angles anteriorly or posteriorly. Here again 1801 shows a bend on the anterior aspect of the lens regarding strut 105.

Fig. 21. Perspective view of an embodiment of the novel lens with closed loop haptic.

2101 Here the standard haptic 103 is in a shape or configuration with a closed loop haptic. This embodiment, as are others, is optimized for optimized for stabilization in the anterior segment. A closed loop haptic can be rotated clockwise or counterclockwise which has advantages when precisely placing a secondary IOL. Note, this novel IOL, in any embodiments, is placed at either the time of cataract surgery, in an aphakic eye, or in an eye with a primary IOL already inside the eye.

Fig. 22. Front view of an embodiment of the novel lens with closed loop haptic.

Fig. 23. Side view of an embodiment of the novel lens with closed loop haptic 2101.

Fig. 24. 2400 Perspective view of an embodiment of the novel lens with closed loop haptic - narrow type configuration.

2401 shows an embodiment with a narrow closed loop haptic. The narrow closed loop shows an embodiment as an example, the distance between the two parts of the loop are between 1 and 6 mm. The radius of curvature of the connecting aspect of the haptic can vary in order to close the loop effectively. Wider spaced opposite aspects of the loop haptic will have a larger radius of curvature, while tighter loops have tighter radii of curvature.

Fig. 25. Front view of an embodiment of the novel lens with closed loop haptic - narrow embodiment.

Fig 26. Side view of an embodiment of the novel lens with closed loop haptic - narrow type configuration.

Fig. 27. Perspective view of an embodiment of the novel lens with closed loop haptics - double configuration. In order to enhance stability, an embodiment of the lens includes two closed loop haptics. These loops axe shown as v- loops. Multiple closed loop haptics are also an embodiment. The proximity of each loop to each other and to the retention strut has many permissible values and ranges.

2701 Applies to the double closed loop nature of the haptics, generally referred to as 103. These double closed loop haptics have the advantage in some embodiments of applying stabilizing forces in two sets for stabilization of the novel IOL in a rotational manner, and to limit movement in a straight horizontal motion (e.g. in the direction toward or away from the aspect of the optic 101 where the strut 105 attaches. Stabilizing in other directions is also obtained with these and more advanced haptic designs. These closed loop haptics may emanate from anywhere on the optic 101, in this embodiment shown they emanate from a sector roughly 60 to 130 degrees away from the strut. The range includes anywhere from 5 to 355 degrees away from the strut going in a clockwise direction where looking at the optic 90 degrees is 3 O'clock, and 180 degrees in 6 O'clock, etc. These closed loop haptics point in the same general direction as shown, where the ends of the closed loops point generally in the 180 degree direction away from the strut. In other embodiments, these haptics emanate away along the direction of a radius line, such that in effect, the closed loop ends point in different directions from each other. Some embodiments have two closed loop haptics (shown), other embodiments have more than two closed loop haptics. The length of these haptics as measured from the distance of the optic 101 to the farthest point on the closed loop is anywhere from 2 mm to 10 mm. If the total length of material is measured, the length of the haptic itself will obviously be longer. The diameter of the haptic can be between 0.05 mm and 3 mm, and in some embodiments the diameter of the haptic is between 0.1 and 1.5 mm.

2703 shows a configuration of a closed loop haptic showing a rounded point, or V- loop. Fig. 28. Front view of an embodiment of the novel lens with closed loop haptics - double configuration.

Fig. 29. Side view of an embodiment of the novel lens with closed loop haptics - double configuration.

Fig. 30. Perspective view of an embodiment of the novel lens with a plate haptic - single plate.

3101 is an example of the embodiment of the novel IOL with a plate haptic. The advantage of the plate haptic embodiment includes a wider base for stabilization. The plate haptic may be of the same polymer or silicone material as the optic 101. In general, all combinations of materials, manufacturing approaches, number of pieces (one two, three, or more), haptics, and accoutrements that help the retention struts attach to the optic and interact with the capsule or otherwise stabilize the IOL. There is typically on plate haptic in the embodiment as shown. Another embodiment combines an optic 101, two plate haptics 3101 and a retention strut 105.

Fig. 31. Front view of an embodiment of the novel lens with a plate type haptic.

3101 This plate haptic is opposite the retention strut 105 used to secure the IOL in the anterior segment. The length of the haptic is longer than the width. In other embodiments, the width may be greater than the length. The edges are rounded and are also more square in other embodiments. In one embodiment, the entire distal end of the plate is rounded or curved. An embodiment of the plate has holes in it, not shown.

Fig. 32. Side view of an embodiment of the novel lens with single plate haptic. The plate haptic 3101 can be the thickness of the optic, thinner, or thicker. The plate haptic in different embodiments has a length and width of any combination, in mm, that allows for stabilization of the IOL in concert with the retention strut.

Fig. 33. Perspective view of an embodiment of the novel lens with a footplate type haptic.

3301 shows the footplates on the haptic that help the haptic engage the sulcus or inside the capsular bag. Two footplates are shown. An embodiment uses one or three foot plates per haptic. Not shown.

3303 is the S aspect of the footplate haptic allowing for a double footplate design. Another example of this type of haptic used with the retention strut 105 and optic 101 is any of typical anterior chamber IOL designs. The novel lens is able to be placed in the anterior chamber, especially if part of the iris missing. Anterior segment placement is preferred with sulcus or bag location for the footplate haptic or any of the haptics generally referred to as 103.

Fig. 34. Front view of an embodiment of the novel lens with a footplate type haptic. Fig. 35. Side view of an embodiment of the novel lens with a footplate type haptic.

Fig. 36. Front view of an embodiment the novel lens with a molded/joined attachment for the haptic 103.

3601 shows a longer retention strut 105 as an embodiment that applies to all variations of the novel lens configuration.

3603 shows an embodiment where the haptic 103 has a "t" type proximal end that supports a molding of the optic 101 around a different material of the haptic to attach the two pieces. This type of molding attachment is used in some embodiments and demonstrates how the strut is connected to the optic (not shown). The strut 105 is drawn longer in this figure, however, the stout 105 is longer in some embodiments and shorter in other embodiments. The retention strut is designed to optimally engage the capsule through a small eapsulotomy hole to help stabilize the IOL in the eye. This diagram also shows 107 the wedge to help engage the capsule that is present in some but not all embodiments of the invention. An expandable hydrogel is employed in some embodiments of the invention.

Fig. 37. Front view of an embodiment of the novel lens with two haptics. This embodiment of the lens has two haptics. The two haptics are of the same type (open loop as shown) or different types in other embodiments such as combining a plate haptic with an open loop haptic or closed loop with open loop. Multiple combinations are available. An advantage to this type of double haptic plus single or double retention strut configuration is that in some situations, a lens stabilized on one side by a combination of a haptic and retention strut may be favored by the surgeon.

3701 points out the double haptic nature of this embodiment.

Fig. 38. Front view of novel lens with two retention struts. Some embodiments of the novel lens contain more than one retention strut. The increased number further secures the IOL in the eye. However, the additional step of piercing not one but multiple (two in this case) small capsulotomies make the insertion procedure more involved. The precise preparation of the eye and eapsulotomy cuts c n make the insertion similar to a single strut lens, however.

3801 shows two retention struts on one IOL device. Thus, an embodiment of this invention has one or multiple (greater than one) retention struts for engagement with the capsule, lens eyelet, or capsular tension ring. 105 is the strut itself, and 107 is the wedge present in some embodiments. 109 is the attachment system for the strut seen in some embodiments.

Fig. 39. Front view of novel IOL with an embodiment showing a lens movement blocker. This embodiment has a small peg at the side of the optic opposite the retention stout to engage the capsule and/or primary IOL optic edge, or IOL generally or primary IOL haptic to minimize any secondary movement that might occur once the novel lens is placed.

3901 lens movement blocker. This peg is located on the optic edge. In other embodiments it is located elsewhere on either the optic 101 or haptic 103. The retention blocker points posteriorly and can engage the primary IOL, primary IOL's haptic, or capsule to create friction between the novel lens and the primary IOL so the location of the novel IOL is secure and stable once the placement is completed and once the instruments are removed from the eye. In 3900, lens movement blocker 3901 is shown with a flat end. 3901 is rectangular in some embodiments. It is round and cylindrical in some embodiments. 3901 can be between 0.05mm long and 5 mm in length. In one embodiment 3901 is 1 mm in length. In other embodiments 3901 is between 0.5 mm and 3 mm in length. 3901 points directly posteriorly in some embodiments. 3901 is angled toward the strut 105 pointing under the optic in another embodiment. 3901 emanates from the haptic 103 in another embodiment. 3901 attaches to the optic 101 or haptic 103 as a mold made of the same material or as a multi -piece system.

Fig. 40. Front view of novel IOL with embodiment showing a pointed lens movement blocker. This embodiment of the IOL with a retention strut has a lens movement blocker 4001 that acts in a similar fashion to 3901. In this embodiment, by way of example - as any similar type of progression blocker is captured in this invention, the progression blocker 4001 is pointed at the posterior and distal end. Thus it engages the capsule, primary IOL optic or edge, or primary IOL haptic easily. 4001 emanates from the haptic 103 in some embodiments. 4001 points directly posteriorly in one embodiment. 4001 has a wedge type cone shape at the tip in one embodiment. 4001 attaches to the optic 101 or haptic 103 as a mold made of the same material or as a multi -piece system. 4001 in one embodiment is directed toward the strut 15. In 4000, lens movement blocker 4001 is shown with pointed end. 3901 is rectangular in some embodiments with a pyramid type pointed tip. It is round and cylindrical in some embodiments with a cone like pointed tip. 4001 is between 0.05mm long and 5 mm in length. In one embodiment 4001 is 1 mm in length. In other embodiments 4001 is between 0.5 mm and 3 mm in length.

Fig. 41. Front view of novel lens with strut, showing viewer cross section for 4200.

4101 posterior to the optic there is a ridge that is curved, runs with the radius of curvature of the optic and helps position the lens or in some embodiments helps to keep this secondary lens separated at least in part from the primary IOL to decrease any inter lens opacities that could potentially develop. (Not visible in the view).

Fig. 42. Cross section of novel lens 4100. This cross section is through the center or near center of novel IOL with retention strut. Note in this embodiment the lens optic 101 is a meniscus lens. Any type of lens configuration is included in the embodiment of the novel lens system including biconvex, piano convex, positive meniscus, negative meniscus, piano concave, biconcave. Any material for the lens suitable for an ocular implant is acceptable, including acrylics, transparent polymers and silicone lenses, hydrophilic, and expandable hydrophilic designs are contained in the embodiment.

4201 shows the positive meniscus lens.

4101 in this figure shows the ridge. This ridge is similar in construct to a lip protruding posteriorly from the optic. The ridge runs 360 degrees around the optic away from the center in one embodiment, or in other embodiments runs for some distance as expressed in degrees less than 360 degrees. The ridge is so short (<5 degrees) in some embodiments that it serves more as a lens movement blocker as described for 3901. The ridge runs for >1C) degrees in some embodiments. In these cases it also serves as a lens movement blocker, but also creates a mechanical space between primary and secondary IOL when the novel lens is placed in a pseudophakic eye. This aspect to the novel lens can, in addition to helping reduce secondary IOL movement, help reduce the chances for interaction between the lenses preventing a lens lens opacification process usually considered related to proliferative tissue. Material interactions may also be prevented if that were to be an issue. 4101 as shown is also multiple in some embodiments. For example, the ridge / spacer is present for 10 degrees, then it stops. Ten degrees later it is present again for ten degrees. There are many configurations and combinations in other embodiments. In one embodiment the ridge space is present in sets of four, in other embodiments, there 4101 is present at the aspect of the optic close to the retention strut 107 (not shown), and also present at the opposite aspect of the strut. It is present in one embodiment only at the strut aspect of the optic. It completely encircles the center of the optic 101 in one embodiment. The diameter of the ridge is 5.5 mm in one embodiment. The diameter is between 2 mm and 10 mm in other embodiments. Gaps as discussed are permitted. The height of the ridge when looking at the lens' posterior surface is between 0.05 mm and 2 mm. In one embodiment the height is 1 mm. The width of the ridge is between 0.05 mm and 3 mm. In one embodiment the width is 0.75 mm. The ridge can be molded from the same material as the optic 101. It is secondarily fused/attached in the manner a three piece optic is joined to haptics in other embodiments. The protrusion separator ridge alone as structure does not need to be combined with the novel retention strut lens and is a novel development for a secondary IOL independent of the retention strut.

Fig. 43. Front view image of an embodiment of the novel lens with a protrusion separator. This front view through the transparent IOL shows the location of the protrusion separator 4301 which is centered in one embodiment.

4301 is the image of the small protrusion separator from the top view of the novel lens. This protrusion separator projects posteriorly from the optic to ensure there is some space between the primary IOL and the secondary novel IOL. 4301 is molded from the same material as the optic in some embodiments. It is the same refractive error as the optic in some embodiments. It is between 0.05 mm and 2 mm in length in some embodiments. Its diameter is between 0.05 mm and 2 mm in some embodiments. Any size protrusion separator that works with this system is feasible including sizes smaller than those described above. Fig. 44. Side view cross section of 4300 novel lens with protrusion separator. The protrusion separator alone as a dimple does not need to be combined with the novel retention strut lens and is a novel development for a secondary IOL independent of the retention strut

4301 shows the protrusion separator projecting posteriorly from a meniscus lens. The lens is any type in other embodiments. Note in this embodiment the lens optic 101 is a meniscus lens. Any type of lens configuration is included in the embodiment of the novel lens system including biconvex, piano convex, positive meniscus, negative meniscus, piano concave, biconcave. Any material for the lens suitable for an ocular implant is acceptable, including acrylics, transparent polymers and silicone lenses, hydrophilic, and expandable hydrophilic designs are contained in the embodiment. The protrusion separator 4301 is molded from the same material as the optic in some embodiments. It is the same refractive error as the optic in some embodiments. It is between 0.05 mm and 2 mm in length in some embodiments. Its diameter is between 0.05 mm and 2 mm in some embodiments. Any size protrusion separator that works with this system is feasible including sizes smaller than those described above. The protrusion separator is also able to help secure the lens and prevent side to side or superior inferior slippage (as related to the subject's eye).

Fig. 45. 4500 is a front view showing the novel lens with two retention struts and a central corrective lens embedded w thin the optic 101.

4501 shows power correction of a different amount compared to the outer lens 4505. The central corrective power of the novel lens 4501 in one embodiment is for presbyopic correction. It adds roughly + 2.5 diopters so that the subject has an improved ability to see near objects. The process of miosis seen during accommodation will enhance the performance at near of the novel lens. As a side point, in bright light the greater constriction of the pupil will counter balance the myopic shift imparted by the central presbyopic correction and the pinhole effect will allow for continued high quality distance vision. The advantages of the novel lens system with retention struts is that the novel secondary lens described herein can be accurately placed in a precise location to optimize vision correction, or presbyopic correction. Based on the examination of the eye or pseudophakic eye preoperatively, the center of the eye's visual axis can be known and the capsulotomy hole can be placed so that the novel lens can be placed in a location to provide optimal or near optimal vision correction. The refractive error and/or other aberrations are measured preoperatively. The exact power of the phakic, aphakic or pseudophakic eye can be determined in advance using objective and subjective means. Thus, the base lens as shown by 4505 or 101, 4901, 5101 or 4701 has the correction to make the eye corrected at distance regarding spherical power, toricity, and higher order aberrations. Then the central power 4501 , if utilized, corrects exactly for optimal or near optimal close vision. The diameter size of 4501 is 2 mm in some embodiments, 1 mm in other embodiments and 3 mm in diameter in other embodiments. The diameter of 4501 ranges between 0.5 mm and 5 mm in various embodiments. 4501 also has the base power of the optic 101 shown as 4505 in some embodiments. The base lens 4505 has no power correction in some embodiments and a wide range of both positive and negative diopter spherical correction combined with tone and other corrections as seen in some embodiments. The lens system 4505 and 4501 is customizable. The power of 4501 can range between negative powers for an over corrected eye and from +0.0 to +0.25 to any positive correction for 4505. Typically 4505 when placed in an emmetropic eye will have a power conection between +0.5 diopters (D) and 3.3 diopters. There are situations where an individualized telescopic lens can be created when combined with a primary IOL of sufficiently related power. This embodiment will prove to be an exceptional alternative for subjects with loss of central vision such as those suffering from macular degeneration. 4501 is molded from the same material is as 4505 or 4701 in some embodiments.

4503 shows two retention struts, each labeled 105. Any combination of retention struts and standard type haptics are to be considered embodiments of the novel device.

4505 is the outer semicircular or ring or donut shape that has optical conective power, not outside the central conection 4501. 4505 has spherical, tone, and/or higher order power. In some embodiments the optic 101 has prismatic correction as well; prismatic conection imparter to 4505 and 4501 in some embodiments.

4505 can be aspheric.

101 can be aspheric.

Fig. 46. Front view showing the novel lens with one retention strut and one standard haptic and a central corrective lens embedded within the optic 101.

4501 shows power conection of a different amount compared to the outer lens 4505. The central conective power of the novel lens 4501 in one embodiment is for presbyopic correction. It adds roughly + 2.5 diopters so that the subject has an improved ability to see near objects. The process of miosis seen during accommodation will enhance the performance at near of the novel lens. As a side point, in bright light the greater constriction of the pupil will counter balance the myopic shift imparted by the central presbyopic conection and the pinhole effect will allow for continued high quality distance vision. The advantages of novel lens system with the retention struts is that the novel secondary lens can be accurately placed in the exact location to optimize vision conection, or presbyopic conection. Based on the examination of the eye or pseudophakic eye preoperatively, the center of the eye's visual axis can be known and the capsulotomy hole can be placed so that the novel lens can be placed in a location to provide optimal or near optimal vision correction. The exact power of the eye or pseudophakic eye can be determined in advance as well. Thus, the base lens as shown by 4505 has the correction to make the eye piano at distance regarding spherical power, toricity, and higher order aberrations. Then the central power 4501 corrects exactly for optimal or near optimal close vision. The diameter of 4501 is 2 mm in some embodiments, 1 mm in other embodiments and 3 mm in diameter in other embodiments. The diametric size of 4501 ranges between 0.5 mm and 5 mm in various embodiments. 4501 also has the base power of the optic 101 shown as 4505 in some embodiments. The base lens 4505 has no power correction in some embodiments and a wide range of both positive and negative diopter spherical correction combined with toric and other corrections as seen in some embodiments. The lens system 4505 and 4501 is customizable. The power of 4501 can range between negative powers for an over corrected eye and from +0.0 to +0.25 to any positive correction for 4505. Typically 4505 when placed in an emmetropic eye will have a power correction between +0.5 diopters (D) and 3.3 diopters. There are situations where an individualized telescopic lens can be created when combined with a primary IOL of sufficiently related power. This embodiment will prove to be an exceptional alternative for subjects with loss of central vision such as those suffering from macular degeneration. 4505 is molded from the same material as 4505 in some embodiments.

4505 is the outer semicircular or ring or donut shape that has optical corrective power, not outside the central correction 4501. 4505 has spherical, toric, and/or higher order power. In some embodiments the optic 101 has prismatic correction as well, prismatic correction imparter to 4505 and 4501 in some embodiments.

4601 shows one retention strut and one standard type haptic. Any combination of retention struts and standard type haptics are embodiments of the novel device.

Fig. 47. Front view showing the novel lens with two retention struts and a central corrective lens embedded within the optic 101 with toric correction. Eyes can have imperfections such as astigmatism that require cylindrical correction. The lines marked by 4701 show toricity and correction of astigmatism in optic 101 in the novel lens. The power is in a specific axis between 0 and 180 degrees based on neutralizing the eye or pseudophakic eye correction. Some embodiments have toricity of a single power lens, and the central lens with different power 4501 is not present. In other embodiments, there is toricity and multiple central lenses (multifocal power).

4701 shows, using parallel lines, toric power correction of the novel lens. The lens is customizable. Embodiments of the lens include correction between +0.25 D to +10 D cylindrical correction at a specific axis as shown by the lines. The IOL is implanted so the lines are at an angle between 0 degrees and 180 degrees to the eye based on the location of astigmatism (axis) for the uncorrected pseudophakic or aphakic eye. Astigmatism is against the rule or with the rule. Typically the reference point on the eye for astigmatism is where 90 degrees is at 12 O'clock or likewise 6 O'clock (vertical) meridian. And 0 or 180 degrees is the horizontal meridian. Any standard reference system is used for marking and orientation of the cylindrical correction. The orientation of the tori city or power is marked on the novel lens with a small notch in some embodiments. The power can be aligned with the strut in single strut embodiments. The power alignment is customizable for eyes where precise placement of the lens strut and/or haptic are driven by ocular anatomy such as capsular rupture or dislocated IOLs. Toric lenses have wide appeal and this embodiment with a retention strut and toric correction allows for accurate and stable toric lens placement.

As mentioned, embodiments as exemplified in 4700 include different (such as presbyopic) central power correction 4501 in some embodiments and not in others. 4501 shows spherical power and or other aberration correction of a different amount compared to the outer lens power and tori city 4701. 4501 contains the toric correction as well as the different power for near or multifocal correction. The central corrective power of the novel lens 4501 in one embodiment is for presbyopic correction. It adds roughly + 2.5 diopters so that the subject has an improved ability to see near objects. The process of miosis seen during accommodation will enhance the performance at near of the novel lens. As a side point, in bright light the greater constriction of the pupil will counter balance the myopic shift imparted by the central presbyopic correction and the pinhole effect will allow for continued high quality distance vision. The advantages of this novel lens system with the retention struts is that the novel secondary lens can be accurately placed in the exact location in the eye's visual axis to optimize vision correction, or presbyopic correction. The lens depth behind the cornea can be accurately predicted for the novel lens because it will rest anterior to the primary IOL or empty capsular bag. This information enhances outcomes. Based on the examination of the eye or pseudopha c eye preoperatively, the center of the eye's visual axis can be known and the capsulotomy hole can be placed so that the novel lens can be placed in a location to provide optimal or near optimal vision correction. The exact power of the eye or pseudophakic eye can be determined in advance as well. Thus, the base lens with tori city as shown by 4701 has the correction to make the eye piano at distance regarding spherical power, toricity, and higher order aberrations. It is placed specifically to align the toric power to correct for astigmatism. Then the central power 4501 corrects exactly for optimal or near optimal close vision. The diameter size of 4501 is 2 mm in some embodiments, 1 mm in other embodiments and 3 mm in diameter in other embodiments. The diametric size of 4501 ranges between 0.5 mm and 5 mm in various embodiments. 4501 al so has the base power of the optic 101 shown as 4701 in some embodiments. The base lens has toric correction in some embodiments and a wide range of both positive and negative diopter spherical correction combined with toric correction 4701 and other corrections is seen in some embodiments. The lens system 4701 and 4501 is customizable As is 4901 and 101. The power of 4501 can range between negative powers for an over corrected eye and from +0.0 to +3.5 to any positive correction for 4505 to improve near or distance acuity. Typically 4501 when placed in an emmetropic eye will have a power correction between +0.5 diopters (D) and 3.5 diopters. There are situations where an individualized telescopic lens can be created when combined with a primary IOL of sufficiently related power. This embodiment will prove to be an exceptional alternative for subjects with loss of central vision such as those suffering from macular degeneration. 4505 is molded from the same material is 4701 in some embodiments. 4701, in some embodiments, has an outer semicircular or ring or donut shape that has optical corrective power with tone and aspheric design (or not) outside the central conection 4501. 4701 has spherical, toric, and/or higher order power. In some embodiments the optic 101 and 4701 has prismatic conection as well, prismatic correction lmparter to 4701 and 4501 in some embodiments. 4501 is not present in some embodiments providing only single power toric, customizable conection.

Fig. 48. Front view showing the novel lens with one retention strut, one standard type haptic and a central conective lens embedded within the optic with toric conection.

The descriptions and comments regarding variations and embodiments recorded for previous drawings of the novel IOL apply here. This figure 4800 shows for diagrammatic purposes that the novel IOL has in one embodiment a one haptic and one retention strut configuration as shown. The haptic may be of any type of haptic including all those mentioned for 103 previously. 4601 shows the configuration described in 4600 with one haptic and one retention strut 180 degrees apart. The figure showing an embodiment with a central lens power different than the base lens 4701. 4701 is a base lens here that has toric power. The central lens 4501 is present in some embodiments and not in others. Orientation is key, particularly for the toric lens 4701 where the axis of the power must be precise for optical visual results. The single strut along with a haptic as shown is able to align the IOL/optic in precise placement. Multiple retention struts are present in some embodiments, multiple haptics 103 are included in other embodiments. Fig. 49. Front view showing the novel lens with two retention struts and a multifocal lens configuration.

The descriptions and comments regarding variations and embodiments recorded for previous drawings of the novel IOL apply here. This figure 4900 shows for diagrammatic purposes that the novel IOL has in one embodiment two retentions struts. Some embodiments have more. Some have less. The novel IOL has a multifocal configuration (distance, near, and mid-range (1 meter - 3 meters in focus). The lens can be placed and secured precisely for optimal results.

4901 shows the multifocal nature of the optic in this embodiment of the novel lens. The concentric rings identify regions of the IOL with a different spherical power correction. In one embodiment, the central lens is greater plus diopters than the next concentric ring, which is greater than the next. In other embodiments the powers are in an alternative order of which many combinations are possible. The base multifocal lens has toric correction in some embodiments. The base multifocal lens has higher order aberration correction in some embodiments. The retention struts have all the possible configurations described in other parts of this application in one embodiment and another. The decision to use a multifocal secondary IOL is well established. This novel lens design improves visual outcomes for patients and makes placement easier for surgeons.

The haptic 103 not shown in this embodiment may be of any type of haptic including all those mentioned for 103 previously. Multiple retention struts are present in some embodiments; multiple haptics 103 are included in other embodiments.

Fig. 50. is a Front view showing the novel lens with one retention strut and one standard haptic and a multifocal lens configuration.

The descriptions and comments regarding variations and embodiments recorded for previous drawings of the novel IOL apply here. This figure 5000 shows for diagrammatic purposes that the novel IOL has in one embodiment one retention strut (variations described elsewhere included) and one standard haptic 103. Some embodiments have more haptics 103. Some have less. Some embodiments have more retention struts 105; some have less. The novel IOL has a multifocal configuration (distance, near, and mid-range (1 meter - 3 meters in focus). The lens can be placed and secured precisely for optimal results.

5001 shows the multifocal nature of the optic in this embodiment of the novel lens. The concentric rings identify regions of the IOL with a different spherical power correction. In one embodiment, the central lens is greater plus diopters than the next concentric ring, which is greater than the next. In other embodiments the powers are in an alternative order of which many combinations are possible. The base multifocal lens has toric correction in some embodiments. The base multifocal lens has higher order aberration correction in some embodiments. The retention struts have all the possible configurations described in other parts of this application in one embodiment and another. All described approaches to multifocal IOL correction make up one embodiment or another of this novel retention strut lens. The decision to use a multifocal secondary IOL is well established. This novel lens design improves visual outcomes for patients and makes placement easier for surgeons.

The multifocal component fits in the smaller central location exemplified by 4501 in some embodiments such that the central lens power is multifocal and there remains base lens 4505 outside the central lens.

The haptic 103 shown in this embodiment may be of any type of haptic including all those mentioned for 103 previously. Multiple haptics 103 are included in other embodiments.

Fig. 51. Front view showing the novel lens with two retention struts and a customized wave front - higher order aberration corrected optic lens configuration. The wave front of the patient is measured using technologies to identify and map higher order aberrations of the eye, and then the optic is designed and fabricated to correct for those aberrations (which are described elsewhere in this application). The customized lens can be placed precisely because of the retention strut configuration.

The descriptions and comments regarding variations and embodiments recorded for previous drawings of the novel IOL and optic apply here. This figure 5100 shows for diagrammatic purposes that the novel IOL with wave front correction has in one embodiment two retentions struts. Some embodiments have more. Some have less. The novel IOL is wave front corrected. A multifocal configuration (distance, near, and mid-range (1 meter - 3 meters in focus) and/or toric, and spherical correction can also be included in the lens optic. The lens can be placed and secured precisely for optimal results.

5101 shows by the curved hatch mark lines the wave front nature of correction in this embodiment of the novel lens. The base wave front corrected or higher order corrected lens has toric correction in some embodiments. The base wave front corrected lens has multifocal and /or presbyopic correction in some embodiments. The retention struts have all the possible configurations described in other parts of this application in one embodiment and another. The decision to use a wave front corrected secondary IOL is evolving. This approach is expected to gain acceptance in the coming years. Laser adjustable lenses as reported in the public domain can be implanted in the eye and then subsequently adjusted. The key advantage of this lens design is that the base or primary IOL is unaffected. The wavefront lens can be removed if the result is not to the patients liking. The novel lens can be separated easily from the retention strut if that is required with an instrument. This novel lens design improves visual outcomes for patients and makes placement easier for surgeons.

Fig. 52. Front view showing the novel lens with one retention strut and one standard haptic and a customized wave front - higher order aberration corrected optic lens configuration. The wave front of the patient is measured using diagnostic and imaging technologies to identify and map higher order aberrations of the eye, and then the optic is designed and fabricated to correct for those aberrations (which are described elsewhere in this application). The customized lens can be placed precisely because of the retention strut configuration

The descriptions and comments regarding variations and embodiments recorded for previous drawings of the novel IOL apply here. This figure 5200 shows for diagrammatic purposes that the novel IOL has in one embodiment one retention strut (variations described elsewhere included) and one standard haptic 103. Some embodiments have more haptics 103. Some have less. Some embodiments have more retention struts 105; some have less. The novel IOL is wave front corrected. A multifocal configuration (distance, near, and mid-range (1 meter - 3 meters in focus) and/or toric, and spherical correction can also be included in the lens optic. The lens can be placed and secured precisely for optimal results.

5201 shows by the curved hatch mark lines the wave front nature of correction in this embodiment of the novel lens. The base wave front corrected or higher order corrected lens has toric correction in some embodiments. The base wave front corrected lens has multifocal and /or presbyopic correction in some embodiments. The retention struts have all the possible configurations described in other parts of this application in one embodiment and another. The decision to use a wave front corrected secondary IOL is evolving. This approach is expected to gain acceptance in the coming years. Laser adjustable lenses as reported in the public domain can be implanted in the eye and then subsequently adjusted. The key advantage of this lens design is that the base or primary IOL is unaffected. The wavefiont lens can be removed if the result is not to the patients liking. The novel lens can be separated easily from the retention strut if that is required with an instrument. This novel lens design improves visual outcomes for patients and makes placement easier for surgeons. The haptic 103 may be of any type of haptic including all those mentioned for 103 previously. Multiple retention struts 105 are present in some embodiments; multiple haptics 103 are included in other embodiments.

Fig. 53. Side view of embodiment with haptic angled posteriorly.

5301 shows tilt of haptic into posterior direction. Angle theta defined as positive, although this angle sign was arbitrarily determined. In some embodiments the haptic 103 may be angled posteriorly. The haptic is angled 10 degrees in one embodiment. The haptic 103 can be at any angle between-40 and +40 degrees.

5303 shows retention strut 105 projection directly out from optic 101. In other embodiments the retention strut is angled posteriorly. In other embodiments the retention strut 105 is angled anteriorly.

Optic 101 is any lens type or configuration as discussed previously.

Fig. 54. Side view of embodiment with haptic angled anteriorly.

5401 shows tilt of haptic into anterior direction. Angle theta defined as negative here, although this angle sign was arbitrarily determined. In some embodiments the haptic 103 may be angled posteriorly. The haptic is angled - 10 degrees in one embodiment. The haptic 103 can be at any angle between-40 and +40 degrees.

5303 shows retention strut 105 projection directly out from optic 101. In other embodiments the retention strut is angled posteriorly. In other embodiments the retention strut 105 is angled anteriorly. The retention strut 105 is angled 10 degrees in one embodiment. The retention strut 105 can be at any angle between-40 and +40 degrees in the anterior posterior plane. The retention strut 105 is angled off from a continuing radius line from the center of the optic in some embodiments. The angle off the radius is ten degrees in one embodiment. In some embodiments the angle is between one degree and 45 degrees, with orientation in either direction possible in various embodiments of the present invention.

Optic 101 is any lens type or configuration as discussed previously.

Fig. 55. 5500 Top view of retention strut ring piece for attachment to optic. One embodiment of several embodiments / methods described generally as 109 in other figures. This ring with two different external diameters and a central smaller diameter is used to attach the retention strut 105 to the optic in some embodiments. The optic has a hole at the edge of the optic in some embodiments and there is a need for a three piece system attachment. Alternatively, in some embodiments this ring structure is molded into the optic and thus the central smaller diameter ring is seamless with the optic itself. 5501 is an entire independent structure in some embodiments. Part of 5501 is present as an independent structure in some embodiments. 5501 or part of it can be molded into 101 in some embodiments or into the retention stmt 105 in some embodiments. 5501 is an independent structure, separately made of a different material, in some embodiments. Thus, for example, the retention strut 105 is an expandable hydrophilic polymer in some embodiments. This ring structure 5501 is made of the strong and durable polymethyl methacrylate in one embodiment, while the optic 101 is made from a flexible acrylic material. Thus, the PMMA 5501 will withstand any deformation imparted by the expanding strut 105 to avoid warping or stress on the optic 101. Any materials or combinations are embodiments of this design with an independent ring-like structure that is used to attach the retention strut 105 to the optic .

5503 is an example of a central opening in 5501.

5501 may have a complete central opening 5503 for the 105 strut to fit. 5501 has a diameter of 1 mm and a height of 2 mm in some embodiments. The height is between 0.5 mm and 4 mm in some embodiment. The diameter is between 0.1 and 3 mm in some embodiments. The central opening diameter 5503 is designed to fit with the retention strut 105 in some embodiments. See discussion of sizes for 105.

Fig. 56. 5600 shows the top view of an embodiment for 109. In this figure the outer ring 5601 is essentially a cap. 105 does not protrude. There is no full opening. The internal diameter 5603 is for the insertion of the proximal (optic end of strut 105) into the structure of the ring. The hash marked line demonstrate that the structure does not have a top opening. In both 5500 and 5600 the internal opening for the retention strut is round. This central opening is alternative shapes in different embodiments including rectangular, square, oval, triangular, or irregular. This cap 5601 in some embodiments has an extra space (not shown) to allow for a locking in of the strut 105 and the piece shown in 5600 or 5500.

As mentioned, the strut 105 is a straight cylinder, square, oval, rectangle or triangle depending on the embodiment. 5601 allows for a snug fit between 105 and the attachment piece 5501 , 5503, 5601 is a molded part of the strut 105 in some embodiments. 5601 provides a method for attaching the strut to the optic. The optic has a hole near the perimeter of a size to connect the separate strut 105 to the optic 101. The hole is made at the time of manufacturing and fabrication of the novel lens. The hole may be 0.2 mm in diameter, 0.5 mm in diameter, 1 mm in diameter, or 1.5 mm in diameter. The hole is between 0.1 mm and 3 mm in diameter depending on the different embodiments of the novel lens. An optic 101 may have one or more holes for the retention strut, which can be singular or multiple. 5600 and 5500 are isolated separate pieces in some embodiments used to attach the strut to the optic. In some embodiments the shape remains, in ranges described herein, but the actual piece 5600 or 5500 is actually molded into either the optic or the strut. In the figures which show some embodiments, the ring is isolated. It is used on any capsular retention strut herein described. The piece is used to attach the novel lens optic to the retention strut, by encircling the strut and interacting with a circular opening on the optic, attachment occurs.

Fig. 57. Side view of retention strut ring piece for attachment to optic. This figure shows that the inner ring has a smaller external diameter than the outer rings aspects. Thus, it can be molded into the optic. The retention strut 105 may have a top cap that sits on top of the entire structure shown in 5700.

5701 shows the inner ring which can engage a hole in the optic. The external diameter engages the optic. It is molded into the optic in other embodiments. The internal diameter engages the retention strut. In some embodiments there is room for the retention strut to expand into the space. In other embodiments the retention strut is a very close fit. Then, the retention strut does not expand in one embodiment. In another embodiment the retention strut expands, but less so proximally than distally. In one embodiment, there is no room for the strut to expand so it is compressed and secure at that point. The retention strut 105 may have a gradient of expansion.

5601 shows the larger external ring. This ring allows for the capture of the optic in some embodiments. The figure shows a double large ring structure. There is only one large ring in some embodiments. This large ring can be either anterior or posterior depending on the embodiment. This piece shown in 5700 is made from any suitable biocompatible material. In some embodiments it is PMMA. In some embodiment it is selected from silicones, acrylics, and expandable hydrogels. This piece is embodied in a range of sizes.

Fig. 58. 5800 shows a side view of the double ring and strut together. In some embodiments the strut 105 and the rings 5601 and 5701 are separate pieces. In other embodiments this is one molded piece. See descriptions for other similar figures. In this embodiment the distal end of the strut 105 extends beyond the plane of the double ring. In other embodiments it stops at the double ring 5601. 109 shows what in some embodiments this structure may look like when viewing figures of the optic that show 109.

107 shows the wedge that projects distally.

105 is shown straight. It is bent or curved in other embodiments of the present invention. Fig. 59. 5900 shows a side view of the strut 105 alone. 105 is fit together in parts to become part of the novel IOL in some embodiments. In other embodiments 105 is molded to the optic.

Fig. 60. 6000 shows the proximal strut and strut ring combination. Here there is no inner ring. The wider double rings 5601 are molded onto the strut in one embodiment. In another embodiment these small rings are independent pieces and are placed around 105. The rings are used to secure the strut to the optic in some embodiments. The distal end of the strut 105 is not shown.

6001 Partial view as distal end of strut not shown.

Fig. 61. Shows the proximal aspect of the strut in side view with a rounded cap. The strut has configurations that allow the strut to connect with the optic 101 not shown.

6101 shows a cap to the strut 105. This strut/cap configuration engages the optic through a hole in the optic prepared during manufacturing. The cap is rounded.

Fig. 62. Shows the proximal aspect of the strut in side view with a rounded cap and a securing ring. This strut/cap/ring configuration engages the optic through a hole in the optic prepared during manufacturing. The cap is rounded. The strut 105 has these attributes molded during manufacturing.

5601 The ring helps secure the strut when the strut cap/rmg combination is placed into the optic so that it does not move. The size of the cap 6101 and ring 5601 are different in different embodiments. The cap is wider than the diameter of the strut. The external diameter of the ring is wider than the external diameter of the strut. The diameter of the strut fits into a manufactured or prepared hole in an optic 101.

Fig. 63. Shows the proximal aspect of the strut in side view with a flat cap. The strut has configurations that allow the strut to connect with the optic 101 (not shown here).

6301 shows a cap to the strut 105. This strut cap configuration engages the optic through a hole in the optic prepared during manufacturing. The cap is flat. Other embodiments of the cap are neither rounded nor flat. The cap is designed to minimize any optical aberrations. It has the same index of refraction as the strut and/or optic in some embodiments. Materials have been discussed elsewhere and apply. The cap has a space to engage the optic when the embodiments are made from two parts. In some views the cap is seen as 109.

Fig. 64 shows the proximal aspect of the strut in side view with a flat cap and a securing ring. This strut/cap/ring configuration engages the optic through a hole in the optic prepared during manufacturing. The cap is flat. The strut 105 has these attributes molded during manufacturing in some embodiments. 5601 The ring (shown below the cap) helps secure the strut when the strut/cap/ring combination is placed into the optic so that it does not move. The size of the cap 6301 and ring 5601 are different in different embodiments. The cap is wider than the diameter of the strut. The external diameter of the ring is wider than the external diameter of the strut. The external diameter ring and cap are the same in some embodiments, different in others. The strut fits into a manufactured or prepared hole in an optic 101. In one embodiment, the cap 6301 and the ring 5601 are simply protrusions from the strut used for securing it to the optic in a two piece configuration.

Fig. 65. 6500 Top view of the retention strut with the cap and ring system plus a bend and the wedge. This figure shows the embodiment such that when the retention strut is combined with the optic (not shown) it points outwardly instead of posteriorly as a perfectly straight strut would. The bend is not visible in this view.

109 is the structure that makes up the top of the retention strut on the optic present in some embodiments (obviously not those where 105 is molded into the optic, for example). 109 is seen on the anterior surface of the optic. The inner circle is a protrusion in some embodiments. The protrusion does not exist, and the cap is flat in other embodiments. There are multiple embodiments that have the strut and optic interact in different ways including those that have thinner and thicker aspects to the optic to enhance the fit and stabilize the connection between optic and retention strut. 107 has been described elsewhere.

Fig. 66. 6600 Side view of the retention strut with the cap and ring system plus a bend and the wedge.

301 shows the bend on the strut once it exits the optic connection. The bend allows the strut to project more in the optic plane than posteriorly. Different angles of bends, between 1 degree and 100 degrees, exist for different embodiments. There are some embodiments where the strut has more than one bend (not shown). One embodiment has the strut attach in the opposite direction where the strut projects anteriorly, and then bends.

6601 shows the dual nature of the cap/ring system in one embodiment. Here there is a slight protrusion on the proximal end of the strut ring/cap system. In some embodiments there is no protrusion. The protrusion is 0.1 mm in some embodiments. Different embodiments have different amounts of protrusion.

Fig. 67. 6700 is a side view of the retention strut with the cap and ring system plus a bend, no wedge at distal end of strut. 6700 is very similar to 6600. There is no wedge at the distal end. 6701 shows an embodiment of the stmt where the distal end that engages the capsule is not a wedge. Here it is gently curved. In some embodiments it is pointed. In some embodiments the end is simply the flat end of a cylinder. In some embodiments there is a variable or gradient expansile design so that the more distal end expands on exposure to hydration greater than the more proximal segment, thereby capturing the capsule once the capsule is penetrated. This rounded design can enter a pre-made small capsulotomy. It is more pointed, but without the wider wedge design in some embodiments.

Fig 68. Isometric view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization disk proximal to end of the retention strut.

6801 is a disk, similar in scope and design to a ring that is more proximal which is used to capture the optic. 6801, however, is more distal on the length of the strut 105. This retention / securitization disk in this embodiment prevents the optic from migrating, moving, or dislocating toward the direction of the retention strut. Thus, once the retention strut engages the capsule in the through through method, or perforates either anterior leaflet, posterior leaflet, or both, the optic / lens system will be blocked from movement toward the end of the strut with this circular disk. This aspect of 105 serves as a lens progression blocker, and is of size sufficient to accomplish this task. The diameter of the disk 6801 is 2 mm in one embodiment. Other embodiments have different diameters of the progression blocker / disk 6801. The inner diameter fits on the strut 105. It is molded in some embodiments. The disk 6801 has a thickness of 0.5 mm in one embodiment. Other embodiments have different thicknesses of the progression blocker / disk 6801. Other similar attachments or variations that accomplish the same goal of limiting progression of the optic toward the retention strut and capsule are an embodiment of the novel lens. The disk 6801 is wider than the small capsulotomy hole made for the strut. 6801 is any material suitable for intraocular lenses and ophthalmic implants. 6801 is expandable hydrophilic in some embodiments.

Fig. 69. Side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization disk proximal to end of the retention strut. Different view of the same structures as described in 6800. 6601 and 6201 also described herein. 107 described herein.

Fig. 70. Different side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization disk proximal to end of retention strut. Different view of the same structures as described in 6800. 6601 and 6201 also described herein. 107 described herein. Note bend 301 helps point the distal end of the optic outwardly so that the strut does not point directly posteriorly yet it can engage a hole in the optic. Bend 301 is between the disk 6801 and the wedge in some embodiments. In some embodiments, there are two bends of the shut.

Fig. 71. 7100 is a side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization T-piece proximal to end of the retention strut. This figure is similar to 6800 through 7000. Here, the aspect of the strut that prevents progression of the strut and secondary additional movement of the optic/lens is "t" piece instead of a disk.

7101 This "t" piece lens progression blocker serves a function similar to the disk described as 6801. Whereas 6801 is a disk, 7101 is simply an aspect that intersects the strut proximal to the distal end so that once the retention strut engages the capsule, the entire novel lens is blocked mechanically from further progression by this piece 7101. 7101 is molded into the strut in some embodiments. 7101 is 2 mm in length in some embodiments. The length and diameter of the "t" piece 7101 varies in different embodiments. The structure is sized to perform the task of helping secure the novel IOL with retention strut. The strut engages the capsule between the distal end (wedge 107 in this figure) and 7101 or 6801 in some embodiments. The IOL is stabilized.

Fig. 72. Another side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and a retention securitization T-piece. This figure is similar to 6800 through 7000. Here, the aspect of the strut that prevents progression of the strut and secondary additional movement of the optic lens system is a "t" piece instead of a disk.

7101 This "t" piece lens progression blocker serves a function similar to the disk described as 6801. Here it is shown on in a view where its length cannot be determined. The length is sufficient to accomplish the goal of preventing movement, but small enough to easily fit through the lens insertion system. It is made of different material than the strut in some embodiments. 7101 intersects the strut proximal to the distal end so that once the retention strut engages the capsule, the entire novel lens is blocked mechanically from further progression by this piece 7101. 7101 is molded into the strut in some embodiments. 7101 is 2 mm in length in some embodiments. The length and diameter of the "t" piece 7101 varies in different embodiments. The structure is sized to perform the task of helping secure the novel IOL with retention strut. The strut engages the capsule between the distal end (wedge 107 in this figure) and 7101 or 6801 in some embodiments. The IOL by the retention strut is stabilized to the capsule between the distal end (wedge 107 in this figure) and 7101 or 6801 in some embodiments. Fig. 73. Side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and retention strut securitization barbs proximal to end of the retention strut. This figure is similar to 7100 through 7200. Here, the aspect of the strut that prevents progression of the strut and secondary additional movement of the optic/lens system is a "v" piece, or barbs instead of a straight "f'-piece.

7301 These barbs prevent the progression of the novel IOL system in the direction of the distal end of the strut. 7301 is a lens progression blocker. There is one or more depending on the embodiment. 7301 serves a function similar to the "t" piece described as 7101. Here it is shown in a view where its length cannot be determined. The length is sufficient to accomplish the goal of preventing movement, but small enough to easily fit through the lens insertion system. It is made of different material than the strut in some embodiments. 7101 intersects the strut proximal to the distal end so that once the retention strut engages the capsule, the entire novel lens is blocked mechanically from further progression by this piece 7301. 7301 is molded into the strut in some embodiments. 7301 projects on each side 2 mm in length in some embodiments. The length and diameter of each barb 7101 varies in different embodiments. The structure is sized to perform the task of helping secure the novel IOL with retention strut. The strut engages the capsule and is prevented from migrating toward the distal end of the strut mechanically by 7301.

Fig. 74. Another side view of the retention strut with the cap and ring system plus a bend, wedge at distal end of strut, and retention strut securitization barbs proximal to end of retention strut. This figure is similar to 7300. Here, the aspect of the strut that prevents progression of the strut and secondary additional movement of the optic/lens system is a "v" piece, or barbs instead of a straight "f'-piece. Here the barbs are shown from a different angle. Two barbs are shown. Some embodiments of the lens strut system have one barb, some have three barbs. The angle of the barb ranges between 90 degrees and 5 degrees from the strut itself. Any angle that allows the strut to stabilize may be employed. The distance from the strut 105 that the barb extends is different in various embodiments. Any biocompatible material is acceptable for 7301 ; two piece and molding is acceptable for different embodiments.

7301 These barbs prevent the progression of the novel IOL system in the direction of the distal end of the strut. 7301 is a lens progression blocker. There is one or more depending on the embodiment. 7301 serves a function similar to the "t" piece described as 7101. Here it is shown in a view where its length can be understood such that it projects off the strut leaving a space between its distal end and the body of the strut. The length is sufficient to accomplish the goal of preventing movement, but small enough to easily fit through the lens insertion system. It is made of different material, than the strut in some embodiments. 7101 intersects the strut proximal to the distal end so that once the retention strut engages the capsule, the entire novel lens is blocked mechanically fiom further progression by this piece 7301. 7301 is molded into the strut in some embodiments. 7301 projects on each side 2 mm in length in some embodiments. The length and diameter of each barb 7101 varies in different embodiments. The structure is sized to perform the task of helping secure the novel IOL with retention strut. The strut engages the capsule and is prevented from migrating toward the distal end of the strut mechanically by 7301.

Fig. 75. 7500 Shows the distal end of the retention strut 105. The proximal aspect is not shown as this figure describes an embodiment enhancing an aspect of the wedge 107.

7501 shows that the wedge can be only half in some embodiments, and does not circle the end of the strut fully. 7501 can encircle between 20 degrees to 360 degrees of the strut. The wedge as described in 107 can have multiple embodiments. The distal end of 105 can be pointed and not extend any wider than the strut. The wedge can be very pointed in some embodiments of the present invention. 7501 shows a variation of the wedge where there is a sharper distal end of 105, and the more proximal aspect that is designed to prevent backward slippage is also sharper and at more of an acute angle to the strut 105 than seen in other drawings of the wedge 107. 7501 extends a maximum of 3 mm from the strut in some embodiments. It extends less in some and more in others.

Fig. 76. 7600 Shows the distal end of the retention strut 105. The proximal aspect is not shown as this figure describes an embodiment enhancing an aspect of the wedge 107.

7601 shows that the wedge can be more pointed and more barbed. 7601 can encircle between 20 degrees to 360 degrees of the strut. The wedge as described in 107 can have multiple embodiments. The distal end of 105 can be pointed and not extend any wider than the strut. 7601 shows a variation of the wedge where there is a sharper distal end of 105, and the more proximal aspect that is designed to prevent backward slippage is also sharper and at more of an acute angle to the strut 105 than seen in other drawings of the wedge 107. 7601 extends a maximum of 3 mm from the strut in some embodiments. It extends less in some and more in others.

Fig. 77. 7700 Shows the distal end of the retention strut 105. The proximal aspect is not shown as this figure describes an embodiment enhancing an aspect of the distal end of 105.

7701 shows that the distal end of 105 can have a flap like aspect that prevents back slippage. 105 does not show a pointed distal end in this embodiment. A pointed distal end of 105 is another embodiment that also uses the flap 7701. Once the distal tip and flap 7701 penetrate the capsule, then the flap piece 7701 can fall back to the resting state (as shown) to prevent back slippage. 7701 encircles between 5 degrees 360 degrees of the strut depending on the version of the embodiment. 7701 is flexible. It passes through the capsule, and then snap back to its position. This position once the strut engages the capsule prevents movement back in the direction of the optic. The wedge as described in 107 can have multiple embodiments, and its appearance is general rather than specific although the wedge 105 as drawn elsewhere is one embodiment. The distal end of 105 can be pointed and not extend any wider than the strut. 7701 shows a variation of the wedge where there is a less sharp (or flat) distal end of 105, and the more proximal aspect that is designed to prevent backward slippage is a flap 7701. 7701 extends a maximum of 3 mm from the strut in some embodiments. It extends less in some and more in others.

Fig. 78. 7800 is a side view of the distal end of the retention strut, no wedge, expansile. The retention strut 105 is made of a material that expands when placed in the eye. For example, the retention strut 105 is made of a hydrophilic polymer that expands with hydration in one embodiment. As shown in 7800, the expansion amount of the strut 105 is the same for the entire structure. When the strut engages the capsule, it expands to tighten the fit / interactions between retention strut and capsule. This tightening secures the novel lens via the retention strut into position— with or without other attributes described for different embodiments. Importantly, the retention strut 105 has in some embodiments greater rigidity when not-expanded so that the strut can be placed through the small opening capsulotomy. In some embodiments that rigidity is a quality of the material in an unchangeable state such as PMMA.

7801 shows the retention strut 105 in its non-expanded or less hydrated state

7803 shows the retention strut 105 has increased in size. It is now in the larger, expanded or more hydrated state. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates are manifest in different embodiments of the novel IOL with retention strut.

Fig. 79. 7900 Side view of distal end of retention strut with wedge, expansile. The retention strut 105 is made of a material that expands when placed in the eye. For example, the retention strut 105 is made of a hydrophilic polymer that expands with hydration in one embodiment. As shown in 7900, the expansion amount of the strut 105 is the same for the entire structure. When the strut engages the capsule, it expands to tighten the fit / interactions between retention strut and capsule. The wedge 107 expands also. This expansion and secondary tightening secures the novel lens via the retention strut with wedge into position— with or without other attributes described for different embodiments. Importantly, the retention strut 105 has in some embodiments greater rigidity when not-expanded so that the strut with wedge can be placed through the small opening capsulotomy. In some embodiments that rigidity is a quality of the material in an unchangeable state such as PMMA.

7901 shows the retention strut 105 with wedge 107 in its non-expanded or less hydrated state.

7903 shows the retention strut 105 has increased in size. It is now in the larger, expanded or more hydrated state. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates are manifest in different embodiments of the novel IOL with retention strut.

Fig. 80. 8000 Side view of distal end of retention strut, no wedge, gradient (or variable) expansile. The retention strut 105 is made of a material that expands when placed in the eye. For example, the retention strut 105 is made of a hydrophilic polymer that expands with hydration in one embodiment. As shown in 8000, the expansion amount of the strut 105 is variable and the expansion in this embodiment is greater distally than proximally. Such a differential expansile property helps secure the strut in the new small capsulotomy, as once placed, the more distal end expands greater than the proximal end decreasing the amount of movement backward toward the direction of the IOL optic. As with other expansile embodiments, when the strut engages the capsule, it expands to tighten the fit / interactions between retention strut and capsule. This tightening secures the novel lens via the retention strut into position— with or without other attributes described for different embodiments. Importantly, the retention strut 105 has in some embodiments greater rigidity when not- expanded so that the strut can be placed through the small opening capsulotomy. The expansion increases in a linear manner, meaning that the amount of expansion at a certain point on the strut, if graphed, would be represented by a straight line. An advantage of gradient expansion is that it puts less pressure or stress on the optic 101 strut 105 junction.

8001 shows the retention strut 105 with variable expansile qualities in its non-expanded or less hydrated state

8003 shows the more proximal aspect of the retention strut 105 has increased in size. It is now in the larger, expanded or more hydrated state. However, the expansion is to a lesser degree than the distal end. Such a gradient expansile property can be determined at manufacture using different concentrations of polymers. By varying the constituent polymer concentrations, a gradient expansion is created. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates, as well as the gradient, are manifest in different embodiments of the novel IOL with retention strut In some embodiments there is a wedge, and in some embodiments there is a lens movement blocker on the strut.

8005 shows the more distal aspect of the retention strut 105 has increased in size. It is now in the larger, expanded or more hydrated state. The expansion is to a greater degree than the proximal end. Such a gradient expansile property can be determined at manufacture using different concentrations of polymers. By varying the constituent polymer concentrations, a gradient expansion is created. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates, as well as the gradient, are manifest in different embodiments of the novel IOL with retention strut.

Fig. 81. 8100 Side view of distal end of retention strut, no wedge, gradient (or variable) non-linear expansile. The retention strut 105 is made of a material that expands when placed in the eye. For example, the retention strut 105 is made of a hydrophilic polymer that expands with hydration in one embodiment. As shown in 8100, the expansion amount of the strut 105 is variable and the expansion in this embodiment is greater distally than proximally. Such a differential expansile property helps secure the strut in the new small capsulotomy, as once placed, the more distal end expands greater than the proximal end decreasing the amount of movement backward toward the direction of the IOL optic. As with other expansile embodiments, when the strut engages the capsule, it expands to tighten the fit / interactions between retention strut and capsule. This tightening secures the novel lens via the retention strut into position— with or without other attributes described for different embodiments. Importantly, the retention strut 105 has in some embodiments greater rigidity when not- expanded so that the strut can be placed through the small opening capsulotomy. The expansion increases in a non-linear manner, meaning that the amount of expansion at certain points on the strut, if graphed, would be represented by a curved line. An advantage of gradient expansion is that it puts less pressure or stress on the optic 101 strut 105 junction. An advantage of nonlinear expansion rate is that it allows for greater expansion at the site of the strut/capsule interaction, and lesser expansion at the proximal end, relative to linear expansion.

8101 shows the retention strut 105 with variable non-linear expansile qualities in its non-expanded or less hydrated state.

8103 shows the more proximal aspect of the retention strut 105 has increased in size. It is now in the larger, expanded or more hydrated state. However, the expansion is too a lesser degree than the distal end. Such a gradient expansile property can be determined at manufacture using different concentrations of polymers. By varying the constituent polymer concentrations, a gradient expansion is created. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates, as well as the gradient, are manifest in different embodiments of the novel IOL with retention strut. In some embodiments there is a wedge, and in some embodiments there is a lens movement blocker on the strut.

8105 shows the more distal aspect of the retention strut 105 has increased in size (swelled) relatively more at some parts than others; the measurement is gauged based on location on the strut 105. 8105 shows the larger, expanded or more hydrated state. Expansion is non-linear for the strut. The expansion is too a greater degree than the proximal end. Such a gradient expansile property can be determined at manufacture using different concentrations of polymers. By varying the constituent polymer concentrations, a gradient expansion is created. This expansion takes place inside the eye. The speed of this change is dependent on the hydrophilic polymer. Many combinations of polymers to vary the expansion ratios and expansion rates, as well as the gradient, are manifest in different embodiments of the novel IOL with retention strut. Many combinations of wedge, non wedge, pointed struts, barbs, rings, etc. as described elsewhere in this application have embodiments with expansile, linear expansile, and non-linear expansile properties.

Fig. 82. 8200 Shows an embodiment where the optic and haptic associated with the novel lens can be expansile. There are embodiments of the novel system where the optic and/or haptic can expand once implanted. The expansion can be variable as described above for the strut.

8201 shows a lens/haptic system made of expansile polymer in the lesser or non expanded state.

8203 shows how the lens and haptic can expand once implanted.

Fig. 83. 8300 Side view of the optic 101 with the strut 105 and wedge 107. This embodiment shows that the strut (double strut depicted) c n simply be placed through a hole in the optic, and can stay secure. The anterior aspect of the optic is down in this diagram. The strut projects anteriorly as well as posteriorly. The proximal (non- wedge) aspect of the strut can be truncated at the optic for molded versions. A bend is not shown here but exists in some embodiments. 8301 shows the strut 105 penetrating the optic through a small hole left at manufacturing. The strut has a small ring or other attribute than enhances capture at the optic during molding. For example, in one embodiment, the optic is molded around a strut.

Fig. 84. Perspective view of the double retention strut system with the strut penetrating the optic (8300). The strut has a small ring or other attribute than enhances capture at the optic during molding. For example, in one embodiment, the optic is molded around a strut.

Fig. 85. Top view of the double retention strut system with the strut penetrating the optic (8300). 105 shows the end of the strut visible on the top of the optic as the strut projects posteriorly. The strut has a small ring or other attribute than enhances capture at the optic during molding in some embodiments. For example, in one embodiment, the optic is molded around a strut. In this embodiment, the strut projects anteriorly as well as posteriorly, with the distal end (with wedge as shown) projecting posteriorly.

Fig. 86. 8300 Different side view of the optic 101 with the strut 105 and wedge 107. This embodiment shows that the strut (double strut depicted) can simply be placed through a hole in the optic, and can stay secure. The anterior aspect of the optic is toward the left in this diagram. The strut projects anteriorly as well as posteriorly. The proximal (non-wedge) aspect of the strut can be truncated at the optic for molded versions. A bend is not shown here but exists in some embodiments.

Embodiments 8300 through 8600 also exist where instead of two struts 105 there is least one strut 105 and one standard haptic 103. Other embodiments have different combinations of struts and haptics.

Fig. 87. 8700 Side view of the optic 101 with the strut 105 and wedge 107. This embodiment shows that the strut (double strut depicted) can simply emanate out of the optic in the plane of the optic. In this embodiment, the retention strut is molded out of the same material as the base optic 101. In other embodiments, the strut is connected in a manner that works for current three piece lens systems where the optic is molded around part of the haptic. This, the optic 101, is molded around part of the retention strut 105 is some embodiments. The retention struts still engage the capsule through a small capsulotomy hole, engaging anterior to posterior. At least one strut is placed through the capsule (anterior, posterior or both) , and can stay secure. The anterior aspect of the optic is down in this diagram. The strut projects in the plane of the optic in this embodiment. A bend is not shown here but exists in some embodiments.

Fig. 88. Perspective view of the double retention strut system with the strut emanating from the optic in the plane of the optic (8700). The optic 101 and the retention strut 105 are in one embodiment molded from the same material. In another embodiment, the strut and optic are made from separate pieces and the retention strut has a small extension or other attribute that enhances capture by the optic during molding. For example, in one embodiment, the optic is molded around a strut with a "t" end piece. The retention strut is 4 mm long in some embodiments. The retention strut may be between 1 mm and 7 mm long in some embodiments. The retention strut is straight in some embodiments. The retention strut is designed to perforate the capsule. The retention strut is expandable in some embodiments. 107 wedge is present in some embodiments. The diameter of the retention strut is 1 mm in some embodiments. It is less in other embodiments. The range of the diameter for the retention strut is between 0.1 mm and 3 mm in different embodiments.

8801 is the optic strut transition, where the strut is in the same plane as the optic. In one embodiment, the optic is molded around a strut.

Fig. 89. Top view of the double retention strut system with the strut leaving the optic in the plane of the optic (8700). The optic 101 and the retention strut 105 are in one embodiment molded from the same material. In another embodiment, the strut and optic are made from separate pieces and the retention strut has a small extension or other attribute that enhances capture by the optic during molding. For example, in one embodiment, the optic is molded around a strut with a "t" end piece. The retention strut is 4 mm long in some embodiments. The retention strut may be between 1 mm and 7 mm long in some embodiments. The retention strut is straight in some embodiments. The retention strut is designed to perforate the capsule. The retention strut is expandable in some embodiments. 107 wedge is present in some embodiments. The diameter of the retention strut is 1 mm in some embodiments. It is less in other embodiments. The range of the diameter for the retention strut is between 0.1 mm and 3 mm in different embodiments.

Fig. 90. Different side view of the optic 101 with the strut 105 leaving the optic in the plane of the optic (8700). This embodiment shows that the strut (double strut depicted) can simply be placed through a hole in the optic, and can stay secure. The anterior aspect of the optic is toward the left in this diagram. The strut projects anteriorly as well as posteriorly. The distal (non-wedge) aspect of the strut can be truncated at the optic for molded versions. A bend is not shown here but exists in some embodiments.

Embodiments 8700 and 9100 also exist (as do many other embodiments) where instead of two struts 105 there is least one strut 105 and one standard haptic 103. Other embodiments have different combinations of struts and haptics.

Fig. 91 9100 Side view of the optic 101 with the strut 105 and wedge 107. This embodiment shows that the strut (double strut depicted) can simply be placed through a hole in the optic at an angle, and can stay secure. The anterior aspect of the optic is down in this diagram. The strut projects anteriorly well as posteriorly. The proximal (non-wedge) aspect of the strut can be truncated at the optic for molded versions. A bend is not shown here but exists in some embodiments.

9101 shows the strut 105 penetrating the optic through a small hole left at manufacturing. In some embodiments, the strut has a small ring or other attribute than enhances capture at the optic during molding. In one embodiment, the optic is molded around a strut. In another embodiment the optic and strut are molded from one material. The strut 105 joins the optic at an angle. In one embodiment this angle is 45 degrees from the optic. There is a range of acceptable angles for the strut. The range is between 0 degrees and 100 degrees. 100 degrees extends the strut distal end anteriorly. Most embodiments of this configuration show the strut at some angle with the distal end pointing posteriorly. In some embodiments alternative variations of the strut optic system are included.

Fig. 92. Perspective view of the double retention strut system with the strut penetrating the optic at an angle (9100). The strut has a small ring or other attribute than enhances capture at the optic during molding, in some embodiments. For example, in one embodiment, the optic is molded around a strut.

9201 shows perimeter radius at the edge of the optic which is present in some embodiments of the optic.

Fig. 93. Top view of the double retention strut system with the strut penetrating the optic at an angle (9100). The proximal end of the strut 105 is visible on the top of the optic as the strut projects posteriorly. The strut has a small ring or other attribute than enhances capture at the optic during molding in some embodiments. For example, in one embodiment, the optic is molded around a strut. In this embodiment, the strut projects anteriorly as well as posteriorly, with the distal end (with wedge as shown) projecting posteriorly. The strut 105 simply penetrates a hole in the optic 101 in some embodiments. Ring and capture systems have been discussed that support attachment of the strut 105 to the optic.

Fig. 94. Different side view of the optic 101 with the strut 105 exiting the optic at an angle with wedge 107 (9100). This embodiment shows that the strut (double strut depicted) can simply be placed through an angled hole in the optic, and can stay secure. The anterior aspect of the optic is toward the left in this diagram. The strut projects anteriorly as well as posteriorly. The proximal (non- wedge) aspect of the strut can be truncated at the optic for molded versions. A bend is not shown here but exists in some embodiments. The angle is different in different embodiments. Embodiments 9100 and 9500 also exist where instead of two struts 105 there is least one strut 105 and one standard haptic 103. Other embodiments have different combinations of struts and haptics.

Fig. 95. 9500 Side view of the optic 101 with the strut 105 and wedge 107. This embodiment shows that the strut (double strut depicted) can simply be placed through a hole that is near directly anterior - posterior in the optic . There is a retention cap 109 and the strut is secure. The anterior aspect of the optic is down in this diagram. The strut truncates at 109, and there is a bend in the strut so that the distal end of the strut projects away from the optic.

Fig. 95. Perspective view of the double retention strut system with the strut penetrating the optic straight on, with a bend in the strut (9500). The strut has a small ring or other attribute than enhances capture at the optic during molding, in some embodiments. For example, in one embodiment, the optic is molded around a strut. Manufacture is a two piece system in some embodiments. Methods to secure the strut 105 to the optic 101 have been described. The bend 301 is different in different embodiments. The wedge is present in one embodiment, not in others. Alternative methods for promoting attachment between strut and capsule are described elsewhere.

Fig. 96 Top view of the double retention strut system with the strut including a bend 9500. The proximal end of the strut 105 is described as 109, which has a ring or widened aspect to promote capture in this embodiment. The optic 101 is molded around part of the strut in one embodiment. In another embodiment, the optic is made with a hole, and secondarily the strut is placed. The strut has a small ring or other attribute than enhances capture at the optic during molding in some embodiments. For example, in one embodiment, the optic is molded around a strut. In this embodiment, the strut truncates near the surface of the optic. The wedge, or other structure / aspect of the strut 105 to enable enhanced capsule strut securitization projects at the distal end of the strut as well as posteriorly. The strut 105 simply penetrates a hole in the optic 101 in some embodiments. Ring and capture systems have been discussed that support attachment of the strut 105 to the optic. 109 shows such a system in this figure.

Fig. 97. Different side view of the optic 101 with the strut 105 exiting the optic with associated bend 301 (9500). This embodiment shows that the strut (double strut depicted) can simply be placed through a hole in the optic, and can stay secure with a cap 109. The anterior aspect of the optic is toward the left in this diagram. The strut truncates at 109 and close to the surface of the optic anteriorly. A bend is not shown here and is at different angles in some embodiments.

Fig. 99. Front view of exemplary traditional IOL. Fig. 100. 10000 Front view of IOL with specially positioned eyelets.

1103 eyelets are round and roughly 1 mm I diameter in one embodiment. Eyelets are not round, but square, triangular, oval, rectangular, or asymmetric or irregular shapes in other embodiments. Eyelet shape and strut configuration are designed to interact spatially in some embodiments.

Fig. 101.10100 Top view of double strutted novel IOL in piggyback fashion in place with primary IOL with eyelets (inside eye). In this figure strut 105 emanates at angle posteriorly and outwardly. Other directions are described for different embodiments.

10101 strut 105 is in eyelet 1103. The novel IOL can join the eyelet primary IOL in two places.

Fig. 102. 10200 Top view of single strutted novel IOL with one standard haptic in piggyback fashion in place with primary IOL with eyelets (inside eye).

10101 strut 105 is in eyelet 1 103.

10201 shows that novel IOL optic is smaller than primary IOL optic in this embodiment.

Fig. 103. 10300 Top view of single strutted novel IOL with one standard haptic in piggyback fashion in place with primary IOL without eyelets (inside eye). In this figure strut 105 emanates in plane of optic.

10301 shows novel optic is larger than primary IOL optic

Fig. 104. 10400 Top view of double strutted novel IOL in piggyback fashion in place with primary IOL without eyelets (inside eye). In this figure strut 105 emanates in plane of optic.

10301 shows novel optic is larger than primary IOL optic

Note in figures 10100 through 10400, the novel IOL optic is larger than the primary IOL optic in some embodiments and smaller in others.

Fig. 105. 10500 side view of novel IOL with two retention struts pointing posteriorly engaging in a stable secured manner the primary IOL which is in the capsular bag. The novel secondary lens is placed outside the capsule. The struts 105 pass through the capsule leaflets. 107 wedge prevents backward slippage. The primary IOL need not be in the bag. The primary IOL is dislocated in some situations and the procedure with the novel lens can still be performed. The two lenses together - primary and secondary IOL— are in piggyback fashion, with two struts through the capsule holding the secondary lens in place.

Fig. 106. 10600 side view of novel IOL with one standard haptic engaging the ciliary sulcus and one retention strut pointing posteriorly engaging in a stable secured manner the primary IOL which is in the capsular bag. The novel secondary lens is placed outside the capsule. The struts 105 pass through the capsule leaflets. 107 wedge prevents backward slippage. The primary IOL need not be in the bag. The primary IOL is dislocated in some situations and the procedure with the novel lens can still be performed. The two lenses together - primary and secondary IOL— are in piggyback fashion, with one struts through the capsule holding the secondary lens in place, and the inferior standard haptic also helping to stabilize the secondary IOL.

Fig. 107. Cross section of eye with primary IOL in the bag, and secondary novel lens in place. Novel lens has two retention struts in this figure.

10701 shows the novel lens in place anterior to the primary IOL in the eye.

Fig. 108. Cross section of eye. Similar to 107, but higher magnified view, anterior segment of eye.

Fig. 109. 10900 Cross section of aphakic eye, with novel lens with two retention struts emanating at an angle, piercing anterior and posterior leaflets of capsule.

10901 novel IOL engaging capsule with two retention struts. The strut has a wedge in some embodiments. The strut has no wedge in some embodiments. There is at least one standard haptic in some embodiments.

Fig. 1 10. 1 1000 Cross section of eye with primary IOL in the bag, and secondary novel lens in place. Novel lens has one retention strut, and one standard haptic which is sulcus fixated in this figure.

11001 novel IOL engaging capsule with one retention struts and one standard haptic placed in the sulcus. The strut has a wedge in some embodiments. The strut has no wedge in some embodiments. The strut projects between the plane of the optic and posteriorly in some embodiments.

Fig. 1 11. 1 1100 Cross section of eye with primary IOL in the bag, and secondary novel lens in place. Novel lens has one retention strut, and one standard haptic which is sulcus fixated in this figure. Anterior segment, magnified view.

Fig. 112. 1 1200 Cross section of aphakic eye, with novel lens with one retention strut piercing anterior and posterior leaflets of capsule, one standard haptic. Fig. 1 13. 11300 Side view of double barreled insertion instrument. This insertion instrument is designed specifically for use with the novel IOL with retention strut. Many modifications to the embodiment exist. This figure is the instrument generally, a hand held surgical device that allows for implantation of the novel lens. It has certain additional attributes making this instrument novel with great utility.

Characteristics unique to the insertion device are several, and not all of these characteristics are present in each embodiment. Embodiments include: A) central cannula or bore opening for the insertion of the rolled or folded IOL into the eye— the IOL comes loaded in the instrument in some embodiments, while in other embodiments the IOL is placed by the surgeon or assistant into this larger bore opening at the time of surgery (the IOL is folded by the assistant or surgeon, or it comes pre- folded in some embodiments); with or without: B) a smaller diameter second bore for infusion of saline solution or balanced salt solution to maintain the anterior chamber during insertion; alternatively the larger bore opening is joined by infusion such that there is positive fluid (or air) pressure into the eye during placement (without this second infusion opening or connection of infusion to the larger bore, intraocular viscoelastic would be placed or a separate infusion port is placed— thus the infusion aspect adds critical value to the instrument, and for use with the novel IOL or any IOL, and is considered to be a component of, or a separate stand alone aspect of, the present invention. ). C) The leading edge of the instrument is sharp such that it is capable of making the corneal incision itself, there is a blade in some embodiments, the blade has a pointed tip in some embodiments, the blade is triangular in some embodiments, the blade is attached to the instrument; D) The instrument has a plunger and can also accommodate an intraocular forceps to help position the novel IOL once inserted; E) The instrument allows for passage of a third device aspect that can create the small capsulotomy integral to placing the strut through the capsule ( capsule creation approaches include a small sharp cutter such as the tip of a needle, thermocautery, electrocautery, radiofrequency energy, or a fiberoptic element to deliver laser energy). The instrument is disposable in some embodiments. It is reusable in others. The passageways exit in a bevel in some embodiments. The figure is not to scale. The infusion contains an antibiotic in some embodiments of use. The key aspect to size and scale is that the instrument can enter the eye through a small incision (4 mm or less) and can be utilized in the anterior chamber to deploy an IOL.

This figure shows the external surface of the hand held instrument. The instrument is round or oval depending on the embodiment. Other shapes and changes to the shape as the viewer moves attention along the instrument are included in this invention. The instrument's length is typical for a hand held ophthalmic instrument. Some examples include an. instrument 2.5 cm in length. The length is as long at 15 cm in some embodiments. Generally, the instrument is between 3 cm and 10 cm long. Any length is permissible. The external diameter is between 1 mm and 6 mm at the distal end. Typically it is between 1.5 mm and 3.2 mm. In one embodiment the tip is 2.8 mm in width. In another it is 2.3 mm in width. The distal end is compatible with either micro or small incision surgical technology. The instrument is tapered so that the distal end has a smaller external diameter than more proximal aspects in some embodiments.

11301 is the infusion connector for the instrument. Fluid including saline solution and balance salt solution to name two, air, or gas is connected to the novel instrument to impart positive pressure into the anterior chamber to keep it formed during surgery. A standard iv or Luer lock connector is used in some embodiments. 11301 connects with or is part of the smaller inner bore of the double barrel instrument. The diameter of the attachment 11301 is the size that best fits with the specific embodiment. The inner diameter ranges from 0.05 mm to 2mm. The inner diameter can approximate the size of an internal needle gauge 34 to 18.

11303 is the distal exit of the separate infusion line. Along the instrument at a spot distal enough so that when the eye has been entered for lens placement, the opening 11303 is located.

11307 is the leading edge of the insertion device. It is pointed in some embodiments. It is a blade in some embodiments. The blade is metal, ceramic, or made from diamond in some embodiments. 11307 represents the area of the instrument near where the lens bore exits the instrument distally. This leading edge is rounded in some embodiments. It is pointed and sharp in some embodiments. It is part keratome in some embodiments. Not to scale.

11309 is the proximal end of the instrument. The lens is pre-loaded in some embodiments. The lens is folded and inserted in some embodiments.

Fig. 114. Cross section of the insertion instrument.

11401 is the internal aspect of the lens insertion cannula. This cannula has an internal diameter to allow for the movement of the novel IOL and insertion out of the distal end. The internal diameter is between 1 mm and 3 mm depending on the embodiment. The internal diameter may taper as the viewer places attention on further distal aspects of the instrument.

11403 is the aspect of the instrument where the lens cannula exits the instrument. The lens cannula exits in a bevel in some embodiments. It is partially at the very end and partially on the side of the instrument in this embodiment. The lens exits via this internal bore at the far end only in some embodiments, on the side and not the end in some embodiment, and partially both end and side in some embodiments. The blade surrounds the exit in some embodiments. 11405 is the proximal end of the internal barrel where the novel IOL is placed, already folded in this embodiment. In some embodiments, the lens is folded and then inserted into the internal opening 1 1405. In some embodiments the device comes with the lens pre-loaded. In other embodiments, a self folding apparatus forms part of the proximal end of the instrument.

11407 Internal passageway of narrow cannula of instrument. In some embodiments this narrow second internal cannula is used for infusion. Infusion helps maintain the anterior chamber during surgical manipulation of the eye. The infusion is fluid or air in some embodiments. The infusion has an antibiotic in some embodiments. The infusion is balanced salt solution in some embodiments. The infusion is connected to an external container of fluid via tubing in some embodiments. The infusion can also be run through the larger opening in some embodiments. In some embodiments there is an internal connection via small holes (one or many) to allow infusion into the other passageways of the instrument. The infusion cannula is very narrow (between 25 and 39 gauge) in some embodiments. The infusion is 25 gauge in one embodiment, and 30 gauge in another. The infusion is the second internal passageway in the double barrel version of the invention.

Fig. 115. 1 1500 Shows side view of the proximal operative end of the surgical instrument. Thus, the instrument is one embodiment at the proximal position is a single cannula. This single cannula can be used for only lens insertion. In some embodiments the infusion line and lens enter the eye through a single cannula. In such a system there is in some embodiments a small connector to the larger cannula for infusion fluid. The figure is not to scale. The key aspect to size and scale is that the instrument can serve as a conduit and be utilized (distally) in the anterior chamber to deploy an IOL. The body and proximal aspects of the instrument can be manipulated in a surgical field by the surgeon.

11 01 is the proximal aspect generally of the single bore cannula for insertion of the lens. Infusion fluid, and other instruments including an instrument to make the capsulotomy hole, a plunger and/or micro- manipulator may be passed through this single cannula.

11503 shows that there is a distal, surgical aspect to the instrument not shown in this figure. The key aspect of 1 1503 is that the lack of detailed drawings of the distal aspect of the instruments shown can apply to other drawings, figures, or designs described or shown in this application, even in cases where other drawings do show a distal end. A different distal end may be substituted.

11 05 is a small conduit that attaches to a larger bore cannula in the instrument. This small cannula represents a passageway for infusion fluid in some embodiments. The open end connects with an infusion source (not shown). In some embodiments, it has other uses. For example in one embodiment, 1 1505 is a wire that allows for the passage of current to the tip of the instrument for embodiments that utilize electro or radiofrequency cautery. In some embodiments, 1 1505 is not present or necessary.

Fig. 1 16. 11600 Side view, cross section by length of double barrel proximal end of instrument. Here there is a separate infusion line for the instrument. This line can infuse gas, air or water based fluid (salt solutions) to help maintain the anterior chamber at a fixed pressure when the lens is inserted. Backward flow is permitted in some embodiments so that the volume of the anterior chamber can remain at an acceptable level as the new lens (novel IOL) is inserted. The instrument has a size compatible with small and micro incision surgery. The external diameter of the instrument is 3.2 mm in some embodiments. It is less than 3 mm in some embodiments. . In some embodiments the external diameter is 2.3 mm. In some embodiments the external diameter is 1.8 mm. The length of the instrument is different for different embodiments. The length is between 22 cm and 12 cm in different embodiments. The internal diameter is large enough to accommodate a rolled for folded novel IOL. The novel IOL is in a dehydrated, partially dehydrate d, or full size state in different IOL/instrument combinations. The walls of the instrument are made from plastics in some embodiments and metals in some embodiments. The instrument is plastic and metal in some embodiments. The walls of the instrument are thin relative to the internal diameter openings to conserve space within the instrument. In some embodiments, the

11601 shows that in a cannula system with multiple (greater than one) bore, there is inevitably non- passageway space taken inside the cannula. 1 1601 shows a thin space inside the double cannula device. In some embodiments a wire runs inside this space 11601 for activating electrocautery. In some embodiments the space is simply wall space.

Fig. 1 17. 11700 Side view, cross section by length of triple barrel proximal end of instrument. The instrument may have three central passageways. One passageway is for infusion fluid. One passageway is for the novel folded or rolled IOL. One passageway is for an instrument that can create a small capsulotomy while the IOL is loaded in the other cannula; that same passageway can also be used for a second instrument to help manipulate the IOL inside the eye. In some embodiments the location of the passageways is different than shown. In general, the largest bore passageway is for the IOL. The next largest is for the instrument that can create the small capsulotomy or for an IOL manipulator. The smallest is for infusion. In other embodiments, the infusion line is larger than the instrument passageway. The infusion line can be connected to the other passageways in some embodiments. The connection can be inside the instrument. In some embodiments there is a second fluid connector 1 1503 that connects to the other passageways. There is a connector 11503 to the other passageways in some embodiments. In some embodiments 11503 connects to only one passageway be it the IOL cannula or the instrument cannula. The instrument has similar dimensions as described previously including a length and external diameter that are compatible with eye surgery and small incision IOL surgery. The internal diameters are compatible with an infusion line, an instrument line, and an IOL line. As mentioned, the lens need be inserted by the surgeon or assistant at the time of surgery. In such a case, the two line instrument is utilized in some embodiments as the larger bore line can be used for both the IOL and the instruments for the capsulotomy and the manipulation instruments. In other embodiments of this design the proximal end of the instrument has different appearing openings. In other embodiments, the internal space (identified as 1 1701) is not as large with regard to the space it occupies. . In other words, there is less space between internal bores. Not drawn to sale.

11601 shows that in a cannula system with multiple (greater than one) bore, there is inevitably a non- passageway inside the cannula. 11601 in this figure shows a thin space inside the triple cannula device. In some embodiments a wire runs inside the space 1101 for activating electrocautery.

11701 shows the third bore in a triple cannula device. This internal bore is used to thread an instrument capable of creating a small capsulotomy as well as an IOL manipulator such as a pick or micro-forceps. Not to scale.

Fig. 118. 11800 Side view, cross section by length of triple barrel instrument; view of middle section. The middle section of the instrument has three internal passageways as described for 1 1700. The proximal end of the instrument has configurations that allow for IOL folding in some embodiments (not shown here). The proximal end also has valves to prevent reflux of fluid in some embodiments (not shown here). The proximal end has protrusions to help the surgeon manipulate the device in some embodiments (not shown here). There is a widening of the instrument proximally in some embodiments (not shown here). Not drawn to scale.

11801 shows that in different embodiments there is a more proximal aspect to the triple bore cannula not shown that can accommodate different shapes, designs, and fittings to enhance the performance capability and ease of use of the instrument. Also, these statements relate to single or double bore instruments as well. The number of lumens is another way of referring to the number of passageways or internal bores inside the instrument. Not to scale. This most proximal end of the instrument can be called the operative end, where the most distal can be called the surgical end. Part of the proximal end is not shown in this figure, because multiple different embodiments are part of the invention.. Additions to the proximal, end, not shown, can include, but are not limited to a widening o the proximal end, a lens folder, valves to prevent reflux, electrical wires for energy, shapes on the external surface to ease manipulation by the surgeon, openings specially designed to fit with instruments for use in the eye, disposable or non-disposable attachments, and other shapes and configurations that make the device perform better. There may be foot pedal connectors, handles, buttons, wheels, and conduit lines that interact with the proximal aspect of the instrument. The proximal aspect not shown is as small or as short as 1 mm in length and with an external diameter of less than 3 mm in some embodiments, or it is several cm in length in some embodiments with an external diameter much wider, in the cm range. Any size or length in between is seen in different embodiments. One aspect of 1 1801 is that the lack of detailed drawings of the proximal aspect of the instruments shown can apply to other drawings, figures, or designs described or shown in this application, even in cases where other drawings show a proximal end. A different proximal end may be substituted.

Fig. 1 19. Side view drawing of the surgical instrument. Dashed lines show internal openings of internal cannulas. In one embodiment of this figure, the instrument has a sharp blade for the corneal incision, and multiple internal passageways for infusion fluid and the IOL. In another embodiment the leading edge is sharp, or very narrow, and is inserted through an incision made by a blade on a separate instrument. That instrument is a standard keratotomy blade in some instances of the use of this novel surgical tool. The lens cannula exits in a bevel in some embodiments. The maximum width of the blade is approximately 2.3 mm in some embodiments. The max width of the blade is 3.2 mm in some embodiments. The rate of taper of the blade is variable and different for different embodiments. The figure is not to scale. The key aspect to size and scale is that the instrument can enter the eye through a small incision (4 mm or less) and can be utilized in the anterior chamber to deploy an IOL.

11901 shows the tip of the instrument is a sharp pointed blade in some embodiments. Thus, the instrument is used to create the corneal incision for the implantation of the IOL. The length of the blade is 1 mm in some embodiments, and longer in some embodiments. The key aspect of the blade is that it is capable of creating the incision, and is short enough such that there is enough room in the eye for the IOL to be placed without the blade crossing all the way through the anterior chamber.

11903 Shows the opening for the IOL (or the large bore cannula) on the side of the blade. The lens cannula exits in a bevel in some embodiments. 11905 is the opening for the infusion, which opens on the opposite side as the larger passagew y in some embodiments. In other embodiments, it opens on the same side as the larger passageway, or the top or bottom surface of the blade.

Fig. 120 shows the cross section of the embodiment of the surgical instrument shown in 11900. As shown, the blade has a sharp tip for penetrating the cornea. As for other figures, there are embodiments of different scale, different lengths, and with alternative proximal designs.

12100 shows the cross section of the embodiment of the surgical instrument shown in 11900 with a curved as opposed to pointed distal tip of the instrument. This design has an angled tip or beveled tip to allow for placement of the instrument. The tip is rounded in this embodiment, not pointed. The instrument can still penetrate the cornea and make an incision. However, in some embodiments, the incision is made by a standard keratome. The rate of taper and width of the blade aspect are different for different embodiments. The total opening that penetrates the eye can be accommodated by a 3.2 mm incision in some embodiments, by a 2.5 mm incision in some embodiments, by a 2.3 mm incision in some embodiments, and by a 1.8 mm incision in some embodiments.

Fig. 121. Shows that the tip of the instrument may be rounded as opposed to pointed. The tip is tapered to allow entry into the cornea.

Fig. 122. Plan view of the double barrel embodiment with the folded IOL in the larger passageway in the instrument. Dashed lines are internal. The instrument is used to insert a folded or rolled novel IOL. The instrument penetrates the cornea at the distal end such that the opening for the passageway for the IOL is inside the eye. The instrument is rotated or manipulated so the leading retention strut is positioned into the capsulotomy. The lens cannula exits in a bevel in some embodiments.

12201 Shows the novel IOL in a rolled or folded state, inside the surgical instrument.

12203 Distal aspect of device to advance IOL through the lumen of the instrument. Shows the leading distal end of the plunger, or manipulator that advances the IOL through the passageway. In this embodiment, the plunger has a forceps / grabber type tip to enhance the positioning and placement capability of the surgeon. The use of a forceps or specially tipped plunger is novel for IOL insertion and an embodiment of the invention. The forceps can have 2 or more jaws. The forceps can grab the IOL or the leading or trailing haptic once the IOL is released from the instrument into the eye. If needed, this forceps can pull the IOL out of the eye for a removal. This instrument or device is rigid in some embodiments and flexible in some embodiments. Materials for use include metal or plastics. 12205 shows the shaft or body of the forceps deployed inside the passageway. This body is flexible in some embodiments, rigid in others. The body of the forceps is connected from a handle to the forceps. There is a button, lever, or otherwise compressible protrusion, or other trigger that when activated opens and closes the forceps. The forceps can be used to push the novel IOL into the eye. It can also be used to retrieve the IOL either back into the cannula of the instrument, or simply out through the incision once the instrument itself is retracted out of the eye.

12207 shows where in some embodiments the instrument begins a bevel shape toward the distal end. In some embodiments the exit 1 1403 is completely contained in a bevel design. In some embodiments, the opening has a vertical edge and beveled edge. Typically, the IOL cannula is beveled such that the opening can slide into the eye with the bevel face up, and since the entire cannula exit 1 1403 is in the eye, the IOL is pushed out completely.

Fig. 123. Plan view of the double barrel embodiment with the folded IOL in the larger passageway in the instrument. Dashed lines are internal. The novel IOL is being pushed out, or extruded from the instrument. The extrusion takes place in the eye. The IOL naturally unfolds or unrolls. The plunger / forceps is advanced inside the cannula to push the IOL out.

12301 shows the novel IOL (one embodiment, with retention strut) exiting the distal end of the instrument. The retention strut is guided directly into the small capsulotomy (or eyelets of a primary IOL ) during implantation.

Fig. 124. Plan view of the double barrel embodiment with the folded IOL exiting the larger passageway of the instrument. Dashed lines are internal. In this embodiment the plunger/forceps that is used to push the IOL into the eye and into position is capable of making a bend. In some embodiments the plunger need not bend. In some embodiments, there is no bend in the passageway / instrument and the lens can be implanted through a straight path. In other embodiments, there is a bend of some degree. The bend, or angle, can be within any range from a few degrees of bend based on the radius of a wide circle, to more than a few degrees of bend. The angle or bend may be up to a 30 degree bend in some embodiments. The instrument is rotated in some embodiments to optimize viewing for IOL placement and to optimize the angle and direction of the IOL from the instrument. The instrument is designed such that the blade tip can easily be held in the anterior chamber and safely away from internal structures during placement.

12401 shows the novel IOL further toward the distal end of the instrument. The retention struts on the IOL can be guided into the small pre-made small capsulotomy hole or eyelets of a primary IOL. The novel IOL can be properly positioned inside the eye. Fig. 125. Plan view of the double barrel embodiment with the folded IOL exiting the larger passageway of the instrument. Dashed lines are internal. The novel IOL is unfolding. The forceps / plunger 12203 is still engaging the novel IOL. In some embodiments the plunger has less direct micro-control of the novel IOL and the combination of the instrument itself along with the plunger are sufficient to position the novel IOL correctly. Likewise, the instrument and forceps can grasp and reposition the IOL if needed. The combination of forceps in the instrument can remove the IOL if needed.

12501 shows the novel IOL outside the instrument. It is unfolding. The retention struts on the IOL are already engaging the capsulotomy or eyelets of a primary IOL. The IOL can be guided into the small pre-made small capsulotomy hole or eyelets. The novel IOL can be properly positioned inside the eye.

Fig. 126. Plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument. Dashed lines are internal. The novel IOL is unfolded. The forceps / plunger 12203 is still engaging the novel IOL. This novel in the example has a central lens of different power than the base lens The base lens has ton city. The central power confers presbyopic correction in one embodiment of the lens / instrument combination. In some embodiments the plunger has less direct micro-control of the novel IOL and the combination of the instrument itself along with the plunger are sufficient to position the novel IOL correctly. Likewise, the instrument and forceps can grasp and reposition the IOL if needed. The combination of forceps in the instrument can remove the IOL if needed.

12601 The novel IOL is now fully unfolded. The micro- forceps, or plunger in some embodiments, is still in contact with the IOL and can provide manipulative control.

Fig. 127. Plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument and further from the instrument inside the eye. Dashed lines are internal. The novel IOL is unfolded. The forceps / plunger 12203 is still engaging the novel IOL. The instrument itself can be retracted while the forceps still holds the IOL in the proper position and helps manipulate the lens to position it optimally. The trailing haptic, or retention strut in other embodiments, is not yet visible. This novel in the example has a central lens of different power than the base lens. The base lens has tori city. The central power confers presbyopic correction in one embodiment of the lens / instrument combination. There have been detailed discussions elsewhere in this application of the various lens combinations that constitute an embodiment of the invention. There are corrective combinations for lens power, and haptic / strut combinations for securing the IOL. A broad range of sizes has been discussed. In some embodiments the plunger has less direct micro-control of the novel IOL and the combination of the instrument itself along with the plunger are sufficient to position the novel IOL correctly. Likewise, the instrument and forceps can grasp and reposition the IOL if needed. The combination of forceps in the instrument can remove the IOL if needed.

Fig. 128. Plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument, the micro forceps is now open inside the eye. The micro-forceps is releasing its grip on the IOL itself. Even open, it can still manipulate the lens a little. Dashed lines are internal. The novel IOL is unfolded. The forceps / plunger 12203 is open and initiating the process where it disengages from the novel IOL. The instrument itself can be retracted while the forceps still holds the IOL in the proper position and helps manipulate the lens to position it optimally. Now the micro-forceps can also begin its retraction from the eye. In this embodiment, the infusion cannula is maintaining the anterior chamber. Other methods to maintain the anterior chamber are: using viscoelastic prior, a separate anterior chamber maintainer, and infusing fluid through the larger bore cannula with a connection and / or valve system. All constitute different embodiments of either the method of use, preparation of the instrument prior to placing it in an eye, or embodiments of the instrument itself. The trailing haptic, or retention strut in other embodiments, is not yet visible. This novel IOL in the example has a central lens of different power than the base lens. The base lens has tori city. The central power confers presbyopic correction in one embodiment of the lens / instrument combination. There have been detailed discussions elsewhere in this application of the various lens combinations that constitute an embodiment of the invention. There are corrective combinations for lens power, and haptic / strut combinations for securing the IOL. A broad range of sizes has been discussed. In some embodiments the plunger has less direct micro-control of the novel IOL and the combination of the instrument itself along with the plunger are sufficient to position the novel IOL correctly Likewise, the instrument and forceps can grasp and reposition the IOL if needed. The combination of forceps in the instrument canremove the IOL if needed.

12801 The plunger / micro-forceps is open so that the IOL can be left inside the eye. The micro-forceps here has several jaws. Some embodiments have two jaws. When the microforceps is this close, it can still manipulate the IOL and haptics. The plunger is also called a guiding structure in some embodiments. The guiding structure has different configurations in different embodiments. The guiding structure does not have forceps in some embodiments. The microforceps is retracted without the IOL into the cannula of the instrument in some embodiments prior to removing the entire instrument from the eye.

Fig. 129. Plan view of the double barrel embodiment with the folded IOL now outside the larger passageway of the instrument, the micro forceps is now open inside the eye. The micro-forceps has released its grip on the IOL itself. The trailing haptic is now clearly visible. It can be grasped and positioned again by the forceps if needed. The micro-forceps is moved away from the IOL when it is properly positioned. The micro-forceps is retracted into the instrument, and the instrument is removed from the eye, leaving the novel IOL in position to confer visual benefits. Dashed lines are internal. The novel IOL is unfolded. In this embodiment, the infusion cannula is maintaining the anterior chamber. Other methods to maintain the anterior chamber are: using viscoelastic prior, a separate anterior chamber maintainer, and infusing fluid through the larger bore cannula with a connection and / or valve system. All constitute different embodiments of either the method of use, preparation of the instrument prior to placing it in an eye, or embodiments of the instrument itself. The trailing haptic, or retention strut in other embodiments, is visible. This novel IOL in the example has a central lens of different power than the base lens. The base lens has tori city. The central power confers presbyopic correction in one embodiment of the lens / instrument combination. There have been detailed discussions elsewhere in this application of the various lens combinations that constitute an embodiment of the invention. There are corrective combinations for lens power, and haptic / strut combinations for securing the IOL. A broad range of sizes has been discussed. In some embodiments the plunger has less direct micro-control of the novel IOL and the combination of the instrument itself along with the plunger are sufficient to position the novel IOL correctly. Likewise, the instrument and forceps can grasp and reposition the IOL if needed. The combination of forceps passed through the insertion instrument can remove the IOL if needed. A blade on an IOL removal system is a novel aspect to this set of inventions.

Fig. 130. Perspective view of different embodiments of insertion instrument. The figure is not to scale. The key aspect to size and scale is that the instrument can enter the eye through a small incision (4 mm or less) and can be utilized in the anterior chamber to deploy an IOL. This aspect of scaling and size determinations has been discussed elsewhere and applies to other figures. In this figure, an embodiment of a different hand-held instrument, the proximal end is wider so the IOL can be self- folded when loaded. The device has edges in the figure, but in some embodiments these edges are rounded. The exit holes are smaller or larger depending on the embodiment. This instrument shown is a triple barrel configuration. A double barrel configuration is also an embodiment. The instrument in the figure has a point, in some embodiments it does not. In some embodiments the point is a blade. In some embodiments there is a bevel into which the passageways open. The instrument can be manipulated by the surgeon's hand. The instrument's passageways are not drawn to scale, as is the case for all instrument drawings. The passageway for the IOL is able to contain a folded IOL and transmit that IOL into the eye. The instrument can be rotated once through the cornea in some embodiments. In some embodiments the body of the instrument (from the midpoint distally) the instrument is rounded, oval or round. There is a rounded body or shaft in many embodiments of the instrument. The rounded or oval nature of the shaft applies to other figures as well for different embodiments.

13001 Housing for the IOL folder. The IOL is inserted in an open or unrolled state. As the IOL is advanced into the cannula or passageway, the lens is automatically folded. There are internal molds, lines, or protrusions to enhance proper folding in some embodiments. 13001 is wider proximally than it is distally. There is a taper in some embodiment. The rate of taper is different for different embodiments.

13003 shows protrusions to enable optimal surgical control of the instrument. In some embodiments there are no such protrusions to enhance surgical control or the surgeons grip. In other embodiments, these protrusions are manifest on other designs. The protrusion such as is shown in 13003 can have a different appearance to accomplish the task of enhancing surgical control. The grips are not drawn to scale. The protrusions are included in the other figures in some embodiments. The proximal end is rounded in other embodiments.

Fig. 131. Side view of a different embodiment of the insertion instrument. The figure is not to scale. The key aspect to size and scale is that the instrument can enter the eye through a small incision (4 mm or less) and can be utilized in the anterior chamber to deploy an IOL. This aspect of scaling and size determinations has been discussed elsewhere and applies to other figures. In this figure the proximal end is wider so the IOL can be self- folded when loaded. The device has edges in the figure, but in some embodiments these edges are rounded. The exit holes are smaller or larger depending on the embodiment. This instrument shown is a triple barrel configuration. A double barrel configuration is also an embodiment. The instrument in the figure has a point, in some embodiments it does not. In some embodiments the point is a blade. In some embodiments there is a bevel into which the passageways open. The instrument can be manipulated by the surgeon's hand. The instrument's passageways are not drawn to scale, as is the case for all instrument drawings. The passageway for the IOL is able to contain a folded IOL and transmit that IOL into the eye. The instrument can be rotated once through the cornea in some embodiments. In some embodiments the body of the instrument (from the midpoint distally) the instrument is rounded, oval or round. There is a rounded body or shaft in many embodiments of the instrument. The rounded or oval nature of the shaft applies to other figures as well for different embodiments. 13103 shows a side view of an embodiment of a small handle for the thumb and forefinger to help manipulate the device in the eye.

Fig. 132 shows a cross section of the instrument seen in 13100. This cross section view shows a triple barrel configuration. Some embodiments are double barrel configurations. The wider internal cannula or passageway is for the IOL. The structure shown in this figure allows for the novel IOL to self fold as it is advanced into the cannula. A plunger of one size and design is used to advance the lens into the narrower part of the passageway. Then, the smaller plunger or plunger / manipulator or plunger / micro-forceps is used to advance the novel IOL into the eye. In this triple cannula embodiment, the other two passageways are used for irrigation/infUsion and a third instrument. In some embodiments the other passageways are the same internal diameters. In other embodiments, either the infusion or the second instrument passageway is the wider of the two. There is a connector for the infusion line, not shown in this figure. The instrument line is used for an instrument that can cut, cauterize, apply laser, or otherwise make the desired small capsulotomy. In some embodiments the instrument and infusion can share the same passageway, and the instrument is double barreled. In some embodiments infusion is also applied to all the other passageways. A system with valves is used in some embodiments. The instrument is not drawn to scale. As discussed, the sizes that make the instrument work best are the preferred embodiment. In one embodiment the instrument is roughly 4 cm long. The external diameter is 2 mm. The thinnest tapered aspect is 4 mm long. Other sizes are utilized for other embodiments. In one embodiment there are internal grooves in the IOL cannula to help fold the IOL. In some embodiments there is no leading keratome blade. In some embodiments there is a leading blade. The openings are on a taper in some embodiments. The openings are on the tapered blade in some embodiments. There is at least 1 mm of blade only before the taper before the opening begins in one embodiments. Various relationships between blade, taper, and opening exist in different embodiments. In some embodiments the infusion exits on the side, not the distal end of the instrument.

11403 shows the end of the IOL passageway. The size is adequate to contain a folded novel IOL. The size is adequate for the folded IOL to move through the passageway. The internal passageway is not drawn to scale. The internal passageway opens in the bevel of the instrument in some embodiments.

13201 shows the internal view of the passageway at its largest point. There are grooves internally in some embodiments to help the lens fold. The novel IOL can be placed in the opening by an assistant or the surgeon. In some embodiments, the instrument is preloaded on arrival. Not to scale. Infusion via a connection is utilized through the largest passageway in some embodiments. In some embodiments there is a valve system to prevent fluid back flow out of the instrument.

1 1701 and 1 1301 are additional passageways. They are not drawn to scale. There diameter may be much smaller than depicted, or larger. In some embodiments the second instrument is a wire. In some embodiments the infusion connects to a passageway with a 30g internal opening, in other embodiments the internal opening is between a 25 g and 30 g internal diameter. Smaller gauges are used in other embodiments.

Fig. 133. Side view of the instrument with the wider proximal end for a lens folder. Finger grips are also seen. The edges are rounded in some embodiments. There are no edges (the instrument is round) in some embodiments. In some embodiments, there are edges, but tapers and rounds as one views from proximal instrument to distal In some embodiments the instrument can be turned or rotated inside the eye without fluid leakage around the wound. The surgical wound, as mentioned elsewhere, is a typical cataract surgery incision. At the largest it is greater than 4 mm. Typically, for this instrument and lens, the incision is roughly 2.3 mm. The incision is 2.8 mm, 3.2 mm, 1.8 mm, or 2 mm in some embodiments. Other incision sizes are seen with other embodiments. The width of the blade is the measure of the incision size. The blade with associated with the instrument discussed in this drawing and other figures in this application (if a blade is indeed part of the embodiment) has a width as described for the incision size.

Fig. 134. Top view of the instrument (when the instrument is placed on a flat horizontal surface with the proximal end inferiorly) for IOL insertion with the wider proximal aspect for lens insertion and folding. As seen here, the aspect of the instrument that enters the eye is rounded. In some embodiments there is significantly less un-utilized space. For example, the relative area in a given plane that is open conduit for insertion of a lens system or for the other cannula / passageways is much greater than space taken up by the walls of the individual cannulas or internal non-open space. There is always some aspect of the instrument that has support structure, because a cannula needs a wall.

13401 is the aspect of the distal instrument. Part of this structure enters into the eye during surgery with this instrument. External dimensions allow for entry in a small incision surgical setting, as described. Here the distal external aspect of the instrument is shown as a rounded exterior. Oval in this embodiment, other shapes are utilized in different embodiments.

11403 is not drawn to scale. It is the conduit for the IOL. The opening is on a bevel in some embodiments. The opening is relatively larger in some embodiments. Fig. 135. Bottom view of the instrument (when the instrument is placed on a flat horizontal surface with the proximal end inferiorly) for IOL insertion with the wider proximal aspect for lens insertion and folding. The entry opening for placing the unfolded IOL is visible as 13201. Internally the opening narrows so the distal aspect of the instrument can be placed through a small incision. The fmger holds, which are seen in some embodiments, are visible.

13501 Shows how the internal opening, or passageway for the IOL, tapers and gets smaller so the lens folds tightly and can be inserted into the eye through a small incision. In some embodiments there are grooves or guides in the internal space to help fold or roll the IOL. The plunger / guide instrument fits tightly into the compartment in some embodiments.

Fig. 136. Cross section of the embodiment of the instrument for IOL insertion and infusion with the wider proximal aspect for lens insertion and folding. In this embodiment the instrument is triple barrel. In some embodiments the instrument is double barrel. In this view the novel IOL can be seen folding so it can be advanced into the instrument for insertion through a small incision. The drawing is not to scale.

13601 shows the novel IOL with a retention strut and a trailing haptic inside the passageway designed for the IOL. The folding is being initiated. The plunger which advances the lens forward from proximal to distal is not shown. The plunger is a micro-forceps in some embodiments. The plunger is blunt, or a pick in some embodiments. Internally the opening narrows so the distal aspect of the instrument can be placed through a small incision. The finger holds, which are seen in some embodiments, are visible. As seen here, the aspect of the instrument that enters the eye is rounded. In some embodiments there is significantly less unutilized space. For example, the relative area in a given plane that is open conduit for insertion of a lens system or for the other cannula / passageways is much greater than space taken up by the walls of the individual cannulas or internal non-open space. There is always some aspect of the instrument that has support structure, because a cannula needs a wall.

Fig. 137. 13700 Side view of the distal aspect of the plunger. The plunger is also a lens guide or a lens advancement device or instrument. The plunger is used to push the IOL distally inside the insertion instrument. The more proximal aspect of the plunger, not shown, is compatible with a hand held rigid or semi-rigid cylinder or handle that is part of the distal aspect of the plunger. In some embodiments it attaches to the plunger by means of mechanical interactions. The plunger is advanced by a wheel or other mechanical system that drives the plunger forward. It is advanced by hand in some embodiments.

13701 shows the distal aspect of the plunger. In this embodiment the tip is cupped internally. In other embodiments, it is flat without cupping. In other embodiments the shape is specifically designed to optimally engage an IOL with a trailing haptic such as 103 or retention strut 105. In one such embodiment, there is space for the trailing haptic or retention strut to fit next to the mos distal aspect of the plunger so that the haptic or strut is not bent or compressed.

13703 shows that the proximal aspect of the plunger / advancement device that is deployed through the instrument is not shown. Many embodiments of the distal aspect exist, some with triggers or buttons to release open and close forceps, or a wheel or handle to advance the device.

Fig. 138. 13800 perspective view of the distal aspect of an embodiment of the plunger or lens guiding device. The distal aspect is cupped in this embodiment. It need not be. The image is not drawn to scale. The proximal end, as discussed, is designed for manipulation by the surgeon to advance the IOL into the eye, and position it correctly.

13701 top of plunger / IOL advancement tool.

Fig. 139. 13900 Cross section view of the distal aspect of an embodiment of the plunger or lens guiding device. The distal aspect is cupped in this embodiment. It need not be. The image is not drawn to scale. In this figure, there is an internal wire or rigid aspect to the plunger that engages the distal aspect. In some embodiments, the entire structure applies the rigidity needed to adequately advance the plunger / lens guide device so that the IOL in turn is advanced through the cannula. The proximal aspect is not shown. Many embodiments of the proximal design exist. The plunger typically fits into the IOL passageway cleanly so that it can move through the internal passageway and advance the IOL with a minimum of resistance. Not to scale.

13901 Internal aspect of plunger / advancement tool on one embodiment. There is a depression inside the tool. Not to scale. Part of the IOL and/or haptic fits into the depression in some embodiments. Can also be called an internal cup.

Fig. 140. 14000 An alternative embodiment of the plunger / IOL guide. The distal tip here is rounded. The tip is flat in other embodiments. The trailing haptic or retention strut is not engaged in some embodiments. The proximal aspect is not shown. Many embodiments of the proximal design exist. The plunger typically fits into the IOL passageway cleanly so that it can move through the internal passageway and advance the IOL with a minimum of resistance. Not to scale.

14001 The distal tip of the lens guiding system is rounded outwardly in this embodiment. There are other configurations for the leading tip of the plunger in other embodiments. Fig. 141. Side view of distal end of micro-forceps that can be deployed in the novel instrument. Not to scale. This embodiment of the combination of the insertion instrument and the micro-forceps is used to position the novel IOL correctly while the larger, single, double, or triple barrel instrument is still inside the eye. The infusion allows the anterior chamber to be maintained. The micro- forceps slides though the IOL passageway or an alternative passageway to push the IOL and/or position it. In some embodiments the micro-forceps is the plunger, or lens advancement instrument. In other embodiments, there is a separate plunger or lens advancement instrument, and the micro-forceps can be introduced secondarily to position the IOL. The Micro-forceps has 2, 3, or 4 jaws depending on the embodiment. The proximal aspect of the device, with the trigger, handle, or otherwise mechanical aspect for opening and closing the forceps is not shown. Many methods, including foot pedal are used in different embodiments to open and close the jaws. The jaws engage the optic, the haptic, or the retention strut as needed to manipulate the IOL. The micro-forceps can be used to remove the IOL if needed.

Fig. 142. Perspective view of distal end of micro- forceps that can be deployed in the novel instrument. This embodiment of the combination of the insertion instrument and the micro-forceps is used to position the novel IOL correctly while the larger, single, double, or triple barrel instrument is still inside the eye. The infusion (not shown, either through an anterior chamber maintainer, or the insertion instrument itself) allows the anterior chamber to be maintained. The micro- forceps slides though the IOL passageway (or an alternative passageway in some embodiments) to push the IOL and/or position it. In some embodiments the micro- forceps is the plunger, or lens advancement instrument, as well as a micromanipulator. In other embodiments, there is a separate plunger or lens advancement instrument, and the micro-forceps can be introduced secondarily to position the IOL. The micro-forceps has 2, 3, or 4 jaws depending on the embodiment. The proximal aspect of the device, with the trigger, handle, or otherwise mechanical aspect for opening and closing the forceps is not shown. Many methods, including a foot pedal are used in different embodiments to open and close the jaws. Not to scale. The jaws engage the optic, the haptic, or the retention strut as needed to manipulate the IOL. The micro- forceps can be used to remove the IOL if needed. The dimensions of the device are such that the device can be placed through the passageways of the insertion instrument. In one embodiment the jaws are 4 mm in length. In one embodiment, the jaws are less or greater than 4 mm in length. In one embodiment the shat of the instrument is 1 mm in diameter. Fig. 143. Cross section of device shown in 14100. The internal, opening of the microforceps shows a system where there is an outer cylindrical tube, and an inner shaft that when advanced or retracted opens or closes the jaws of the micro- forceps. Other methods of opening and closing the forceps are utilized in other embodiments. This version has three or four jaws. Some embodiments have two jaws.

12205 shows the outer housing of the micro-forceps. This outer housing is large enough to accommodate the internal structure of the device that attaches directly to the j ws.

14301 The internal structure of the micro-forceps is shown as 14301. This shaft connects directly via a small joint to the forceps so that when the shaft is retracted or advanced the jaws open or close. The dimensions of the device are such that the micro- forceps fits through the novel insertion instrument. The jaws are sized to be able to grasp the IOL, haptic, or retention strut.

Fig. 144. Side view of distal end of micro-forceps that can be deployed in the novel instrument. Not to scale. Two jaws, not three, are utilized in this embodiment. This embodiment of the combination of the insertion instrument and the micro-forceps is used to position the novel IOL correctly while the larger, single, double, or triple barrel instrument is still inside the eye. The infusion allows the anterior chamber to be maintained. The micro-forceps slides though the IOL passageway or an alternative passageway to push the IOL and/or position it. In some embodiments the micro-forceps is the plunger, or lens advancement instrument. In other embodiments, there is a separate plunger or lens advancement instrument, and the microforceps can be introduced secondarily to position the IOL. The Micro-forceps has 2, 3, or 4 jaws depending on the embodiment. The proximal aspect of the device, with the trigger, handle, or otherwise mechanical aspect for opening and closing the forceps is not shown. Many methods, including foot pedal are used in different embodiments to open and close the jaws. The jaws engage the optic, the haptic, or the retention strut as needed to manipulate the IOL. The micro- forceps can be used to remove the IOL if needed.

14401 Two jaws in this embodiment of the micro-forceps.

Fig. 145. Perspective view of distal end of micro- forceps that can be deployed in the novel instrument. Two jaws, not three, are utilized in this embodiment. This embodiment of the combination of the insertion instrument and the micro- forceps is used to position the novel IOL correctly while the larger, single, double, or triple barrel instrument is still inside the eye. The infusion (not shown, either through an anterior chamber maintainer, or the insertion instrument itself) allows the anterior chamber to be maintained. The micro-forceps slides though the IOL passageway (or an alternative passageway in some embodiments) to push the IOL and/or position it. In some embodiments the micro- forceps is the plunger, or lens advancement instrument, as well as a micro-manipulator. In other embodiments, there is a separate plunger or lens advancement instrument, and the micro-forceps can be introduced secondarily to position the IOL. The micro- forceps has 2, 3, or 4 jaws depending on the embodiment. The proximal aspect of the device, with the trigger, handle, button, or otherwise mechanical aspect for opening and closing the forceps is not shown. Many methods, including a foot pedal, are used in different embodiments to open and close the jaws. Not to scale. The jaws engage the optic, the haptic, or the retention strut as needed to manipulate the IOL. The micro-forceps can be used to remove the IOL if needed. The dimensions of the device are such that the device can be placed through the passageways of the insertion instrument. In one embodiment the jaws are 4 mm in length. In one embodiment, the jaws are less or greater than 4 mm in length. In one embodiment the shat of the instrument is 1 mm in diameter.

Fig. 146. Cross section of device shown in 14100. The internal opening of the microforceps shows a system where there is an outer cylindrical tube, and an inner shaft that when advanced or retracted opens or closes the jaws of the micro- forceps. Other methods of opening and closing the forceps are utilized in other embodiments. This version has three or four jaws. Some embodiments have two jaws.

12205 shows the outer housing of the micro-forceps. This outer housing is large enough to accommodate the internal structure of the device that attaches directly to the jaws.

Fig. 147. 14700 Side view of device used through the insertion instrument to create the small capsulotomy for the retention strut to engage the capsule in a penetrating manner. Proximal aspect is not shown. The device has an actuator button or switch, not shown, to turn on the current or energize the tip. The switch is a foot pedal in some embodiments. The depiction here is an electro cautery or thermocautery system. In a thermal cautery system, the tip is heated to a sufficient degree to coagulate the protein of the capsule and create a small controlled opening. There is a battery or other source of energy for powering the wires for the thermocautery or electrocautery. There is a loop tip in some embodiments of the cautery system used through the insertion instrument. The loop may be very narrow or wider. The loop fits through the insertion instrument passageway. There are other tips in other embodiments. The figure also represents an. electrocautery system in another embodiment. The tip has a small gap at the tip in some embodiment for the current to engage the tissue of the capsule. In another embodiment the electrocautery is monopole. In some embodiments it is bipolar. The device, whether thermo- or electro- cautery can be deployed through the IOL passageway, or an alternative passageway. The device is combined with the retention strut and novel insertion system to establish a novel method for securing an IOL in an eye. The instrument uses wires in one embodiment. In another embodiment, the instrument uses sharp mechanics only to create the small capsulotomy. Not drawn to scale.

14701 shows the body, housing or shaft of the device or tool that is advanced through the instrument in some embodiments to create the capsulotomy. In some embodiments the housing or shaft carries energy for cautery. Inside the housing there are wires in some embodiments to energize the leading edge wires of the instrument. The dimensions allow for deployment, advancement and retraction, through the insertion instrument. The housing has insulation capacity in some embodiments. The distal aspect connects to the shaft.

14703 The tip of an embodiment of a device for making the small capsulotomy. The tip gets very hot in some embodiments. The tip can reach 2000 degrees F in some embodiments. The ideal temperature is that which consistently creates a small capsular hole when activated and touched to the capsule. The shape of the wires is such that the tip forms a nearly round distal footprint in some embodiments. The two wires may be very close together in some embodiments. In some embodiments a nonconductive material takes up space between the wires. In some embodiments, there is air or open space between the two wires. The tip is a sharp blade or needle like point or tip for mechanical decision of the membrane in some embodiments. The tip is not drawn to scale.

Fig. 148. 14800 Side view of device used through the insertion instrument to advance and/or manipulate the novel IOL. The IOL is advanced through the insertion instrument by a plunger type device that fits in the passageway. The plunger type device in this embodiment has a pick at the distal end. Not to scale. The proximal aspect that controls the advancement such as a shaft or handle is not shown. The plunger is also a pick in this figure. The pick also can be called a hook. The plunger can be separate from the pick. The pick may be advanced secondarily through the insertion instrument to manipulate the IOL if needed. The hook or pick is used to position and manipulate the novel IOL, haptics, and /or retention strut. The bend in the pick mid-way in its length as shown at 14807 can be any of multiple varieties of angles depending on the embodiment. In some embodiments there is no bend. The length of the most distal bend 14809 can be 90 degrees in some embodiments. In other embodiments the bend is less than 90 degrees or greater than 90 degrees. The pick fits through a passageway in the insertion instrument. The absolute length of the pick is variable and depends on the embodiment. The key is it can manipulate the IOL inside the eye. The pick can be shaped to move the iris in some embodiments. The pick fits with the insertion instrument. It can be advanced and retracted through at least one of the passageways inside the insertion instrument. As are the other components described herein, the pick is compatible with the system for preparing the insertion instrumentation, and inserting a novel IOL into the eye.

14801 shows the very distal protrusion that is not in a direct line with the next most distal aspect of the pick. The length of this most distal inflection / pick is 1 mm in some embodiments less or more in some embodiments. This tip is a small diameter cylinder in some embodiments. It is pointed in some embodiments. The tip can be manipulated by the surgeon to engage the optic or haptic of the IOL. It can also interact with the retention strut or aspects of the retention strut to help it securely engage the capsule.

14803 is the middle aspect of the pick. It is wider than the tip in some embodiments. There is a taper in the diameter from wider to narrower as one moves distally along the pick. The pick is rigid enough to engage the IOL or haptic or retention strut. It is plastic or metal in different embodiments.

14805 The more proximal aspect of the pick itself is a transition zone to a wider, more stable handle. This transition is shown as 14805 in this embodiment.

14807 is the angle between the most proximal (14811) and middle aspect (14803) of the pick. This angle is any angle between 0 degrees and 90 degrees in different embodiments. In some embodiments the angle is 10 degrees. In some there is no perceptible difference in transition from 1481 1 to 14803. The pick typically narrows or tapers as one moves from proximal to distal.

14809 is the angle between the most distal tip 14801 and 14803. This angle is variable depending on the embodiment. In one embodiment this angle is 90 degrees. The key aspect of the bend is that it allows for the engagement of the optic, haptic, or retention strut with the pick. The distal aspect of the tip 15801 is curved in some embodiments. The distal connector forms a "C" at the next most proximal joint in some embodiments.

1481 1 is the most proximal aspect of the pick before it joins, meld, or transitions to the handle aspect of the pick. This aspect of the pick is typically wider than the distal tip. The image is not to scale.

14813 is the shaft of the instrument Fig. 149. 14900 Front view of eye with decentered primary IOL and well-centered novel secondary IOL with retention shut. As is well known to ophthalmic surgeons, despite the best intentions and quality of the instruments and skill of the surgeon, a primary IOL can decenter. The primary IOL in some cases, especially when premium IOLs are used performs best when the IOL is centered on the visual axis. When a premium lens decenters, the visual quality experienced by the patient declines. The IOL's can also tilt with untoward visual effects. Repositioning is not always easy, acceptable, or even possible. The new IOL with retention struts is designed to effectively correct for decentration and other visual disturbances caused by primary IOL movement or position change. Also, the patient may select a single power IOL, and secondarily by relying on the excellent stability of the novel IOL, the premium aspect can be added back at a future date— in the optical axis with the novel IOL. Here the primary IOL is decentered inferiorly, and the novel IOL is positioned with retention strut through the capsule in the visual axis. The haptic 103 of the secondary novel IOL is in the sulcus, while the haptic of the primary IOL is in the bag in this figure.

14901 shows the decentered primary IOL optic. The optic is shown as an example for understanding the benefits of the novel IOL stabilized with one or more retention strut. The capsular bag is often very stable, with fibrosis securing the IOL and capsular bag in one position. The IOL can move or decenter for a variety of reasons. The IOL and capsule can move together in some situations. The capsular bag is still stable enough for additional IOL surgery in many situations. An advantage of the novel system is it is fast and easy to enter the eye. The novel lens can be quickly placed and the instrumentation is removed with minimal risk.

14903 shows the well centered novel secondary IOL with retention strut 105 in place through the capsule.

433 shows the pupil which is centered around the visual axis in this example.

Fig. 150. 15000 is a cross section view of anterior segment of the eye with decentered primary IOL and well-centered novel secondary IOL with retention strut. This view shows how the novel IOL can be placed in the optical axis when a primary IOL is out of the axis. The benefits are many. The novel IOL can be customized to correct for aberrations that develop because of primary IOL decentration. All of those optical corrections are encompassed in the invention. The novel IOL sits and is secured anterior to the primary IOL. The retention strut is critical to securing the novel IOL.

15001 this line represents the visual axis of the eye. The optical performance of the eye is centered around the visual axis of the eye. An IOL is ideally placed in the optical axis of the eye. In the figure 15000 the novel secondary IOL is in correct position. he optical axis of the IOL is in the same line as the optical axis of the eye.

150003 this line shows the optical axis of the primary IOL. It is decentered, and not aligned with the optical axis of the eye. This decentration is associated with decreased performance of the IOL as it relates to vision quality. The novel IOL can correct problems associated with decentration.

Fig. 1 1. This figure shows a cross section of the eye with the insertion instrument in the eye. It is not to scale. It is an example of the utility of the instrument and novel IOL. The instrument makes the incision and is advanced into the anterior chamber. An infusion line contained within keeps the anterior chamber formed. The IOL is placed through a passageway into the eye. The instrument itself or a secondary instrument passed through a passageway can manipulate the secondary IOL. The small capsulotomy is either made by an external energy source such as a femtosecond laser, or by an instrument advanced through the instrument to make the small capsulotomy so the retention strut can engage the capsule.

15100 shows the insertion instrument in the eye. The IOL and other instruments can be passed through this device to place the novel IOL and to manipulate it if needed. There is infusion in some embodiments. The instrument is removed forming a small incision that self seals.

Fig. 152. 1 200 is a front plan view of an embodiment of the novel IOL with retention struts and an opaque ring around the center of the optic. This lens is used to treat aniridia and iris abnormalities so that the eye appears more normal cosmetically and it also reduces glare and reflections in certain situations. The opaque ring is black in some embodiments and iris colors in others. The opaque aspect is made from biocompatible coloring agents including carbon black and other pigments safe for intraocular use. Not to scale.

15201 shows the central opening for the optic that refracts light. It is centered on the visual axis of the eye. The size of the opening is different for different embodiments. The opening is 3 mm across in some embodiments, less or more in different embodiments. Any refractive power is used as needed in this aspect of the optic.

15203 Shows the opaque light blocking ring aspect of the IOL optic. The band reflects or absorbs light thereby correcting cosmetic and optical problems that existed for the eye prior to the placement of this novel IOL with opaque aspects.

In one embodiment the intraocular lens with retention strut is capable of engaging with the anterior capsule in a penetrating manner. The retention strut has a wedge in some embodiments. The retention stmt has a progression blocker in some embodiments. The intraocular lens has haptics generally designed to secure the lens in the capsular bag in some embodiments.

Figure 153: the novel lens is shown in an embodiment of the invention. 15301 is showing the retention strut, here with a right angle bend, a wedge, and a progression blocker. Here the retention strut projects anteriorly and is an example of how the novel lens with retention strut can be used to engage the anterior capsule leaflet only. The wedge is shown at the distal end of the retention strut that will engage the anterior capsule leaflet, but in some embodiments a wedge is not needed. The retention strut engages or penetrates the anterior capsule from posterior to anterior in this embodiment. The retention strut may have a progression blocker, which is shown, to enhance fixation, stabilization, or securitization, of the optic and intraocular lens or the retention strut specifically. Alternatively, in some embodiments, a progression blocker is not needed. In this figure, there is a bend in the retention strut of approximately 90 degrees directing the distal end anteriorly. This bend may be any angle from zero degrees to 165 degrees. If the bend is zero degrees, the retention strut is straight. However, a straight retention strut may project outwardly in a radial direction and at the same time be directed anteriorly generally allowing for the engagement of the anterior leaflet of the capsule. There may be a bend even if the retention strut projects outwardly out of the plane of the optic. There may be one or more bends. All descriptions of possible retention strut attachments to the intraocular lens, expandability, and modifications to enhance fixation described in this application can be combined with this described design for anterior capsular leaflet fixation. Likewise, the different descriptions of the possible wedges and progression blockers can be used with this embodiment and further comprise embodiments of the invention. In this figure one traditional haptic is shown. In some embodiments, there are two traditional open loop haptics and one retention strut. There may be any number of alternatively designed haptics. There may be one or more retention struts. If the lens has a plate haptic, one or more retention struts may emanate from the plate haptic. The retention strut in this figure is shown projecting first outwardly, then with a bend. The retention strut starts pointing posteriorly then bends around the optic greater than 90 degrees to eventually end up facing anterior for engagement with the anterior capsule in some embodiments. The retention strut emanates directly anteriorly in some embodiments, or at an angle but generally anteriorly.

Figure 154: The lens embodiment of Figure 153 in the eye. Shown in this diagram is the retention strut engaging only the anterior capsule from a posterior to anterior directionality, with the lens in the capsular bag. Again, 15301 shows the retention strut in the embodiment where it engages the anterior capsular leaflet from an in the bag fixation of the intraocular lens. The anterior capsule is engaged with a penetration of the leaflet in some embodiments. The engagement may be frictional. This diagram shows the retention strut on optic 101 which may be a primary or secondary intraocular lens. Regardless of whether the intraocular lens optic is secondary, piggy back, or primary, the optic is single power, toric, multifocal, accommodating, pin hole, personalized, presbyopic correcting, or higher order aberration correcting in different embodiments. The novel intraocular lens is single piece or multipiece depending on the embodiment. The retention strut is molded in the same material as the optic and or other haptics in some embodiments. In this figure, there is one haptic. In some embodiments there is more than one haptic. In some embodiment there are more than one retention struts. The retention strut is a separate piece attached to the optic during manufacturing in some embodiments. The placement of this novel intraocular lens with the retention strut can be combined with intraoperative optical aberration assessment including refraction measurement, and real time analysis to help ensure optimal lens placement. In some embodiments the use of the novel lens with retention strut is combined with real time intraoperative refraction and forms a novel system. It is understood that in Figures 153 and 154, the diagram is an embodiment, and there are modifications to the design that still encompass the spirit and broad scope of the invention generally. These figures show the utility of the current invention for enhancing in the bag lens fixation and stabilization. Such improvements will allow for more accurate postoperative vision correction results. Other modifications described in other aspects of the invention have retention struts that project posteriorly. Some advantages of anterior directional fixation are that the anterior lens capsule at this location is easier to access surgically, and retention strut can be more easily visualized because the instrument helping place the lens can be placed behind the strut to push it forward, which may or may not be necessary surgically.

In one embodiment the intraocular lens with retention strut is capable of engaging with the anterior capsule in a penetrating manner. The retention strut enhances stability and fixation and decreases by at least one the degrees of freedom for the optic. The retention strut has a wedge in some embodiments. The wedge is expandable with hydration is some embodiments. The retention strut has a progression blocker in some embodiments, in others the bend or optic serves as a progression blocker. In some embodiments there are no haptics attached to the intraocular lens. In some embodiments the intraocular lens has haptics generally designed to secure the lens in the capsular bag.

In some embodiments the retention strut can move with respect to the optic. The movement is due to the plasticity or flexibility of the polymer in some embodiments. There is flexibility in the components of the strut which allow for movement with respect to the optic. In some embodiments the intraocular lens, when isolated without external forces upon it besides gravity, has a retention strut that projects above or belo the plane of the optic. In some embodiments when external forces are applied to the intraocular lens and retention strut (such as when it is placed in the capsular bag and viscoelastic material has been removed), the leaflets of the capsule can compress or push on, or exert force on the retention strut to move it with respect to the optic. In such a setting the retention strut is directed generally anteriorly or posteriorly in a direction toward the optic, and thus in the opposite direction of its projection in its primary resting position. In this situation where external force from the capsule is applied to the retention strut and optic system there is potential energy that exists within the retention strut design to release when the opening in the capsule is made such that the alignment of the retention strut moves back to or closer to the primary position. Thus, the retention strut exerts tension on the leaflet of the capsule, and has a potential energy that converts to kinetic energy to move the distal end of the retention strut, with or without the wedge, into the hole made in the capsule by the surgeon. The compression or alteration of shape and secondary return to closer to the manufactured state allows for the retention strut to move into position engaging the capsular leaflet. This design, with the compression by the capsular leaflets, and secondary outward pressure exerted on the capsule by the retention strut structure allows for, in some embodiments, constant but gentle pressure on either the anterior or posterior capsule (depending on which embodiment) to help keep the optic from moving once placed in proper position. The retention strut has a flexibility in some embodiments where it can be bent, but not break, and can return to its prior alignment and shape based on memory of the polymer to its original manufactured state. The advantages of embodiments where the retention strut can move relative to the optic, be altered in relative position and thereby contain potential energy and a tendency to return to its original alignment are that the retention strut can A) put gentle pressure on the capsule to hold the intraocular lens in place, and B) in some embodiment the distal end of the retention strut can spontaneously advance into the created hole in the capsule when positioned such that the distal end of the strut aligns with the hole in the capsule. The force generated by the tendency of the material to return to its original state is enough in some embodiments to push the wedge through a small capsular hole. These characteristics enhance the engagement and procedural process of securing the intraocular lens with the retention strut in the eye to generate more favorable visual results for the patient. These characteristics also reduce the need for manipulation of the retention strut into the capsular hole with small instruments during surgical placement of the IOL. The retention strut has a flexible bend or a hinge or joint structure designed and manufactured into the bend of the strut, in some embodiments, to enhance the compressibility or shape altering aspect and secondary return, and engagement of the retention strut to the capsule. The retention strut can engage the capsule automatically in some embodiments. The retention strut mechanically self activates to engage the retention strut to the capsule in some embodiments.

In some embodiments a needle or sharp instrument with a bend is used within the eye to create the hole in the capsule. Likewise, a laser, electrocautery tip, or thermal device has a bend to enable surgical placement in the eye in the correct location for the creation of a precise and small hole in the capsule through which the wedge or distal end of the retention strut penetrates or engages a leaflet of the capsule.

The retention strut can be attached to a plate haptic, at any point on a plate haptic.

In some embodiments the retention strut itself is made from two or more pieces of material. In some embodiments, whether with a multipiece retention strut, or a molded single piece retention strut there is a taper. In some embodiments the taper is not symmetric or regular. In some embodiments the retention strut has several distinct shapes as the view of the retention strut moves outward from the optic. In some embodiments the retention strut is joined to the optic via attachment to a molded protrusion manufactured into the optic. The molded protrusion is made of any applicable shape including designs that have an oval, square, trapezoidal, rectangular, or circular characteristic— or uses parts of these shapes. These exemplary shapes typically have a thickness (side view) no greater than the optic itself. They project from the optic outwardly in a manner similar to as can be seen with a plate haptic. These protrusions for attachment of a retention strut can be called projections or extensions from the optic. Thus, there is a thin extension beyond the edge of the optic for attachment of the retention strut. For purposes of this invention, when the terms "attached to the optic" are used, in some embodiments it is considered attached to the optic when the retention strut is attached to an aspect of the optic that extends outwardly for the purpose of providing a base or point of contact for the retention strut. The shape of this extension when viewed from the top down can be oval, triangular, trapezoidal, rectangular, a half circle, or part of an oval or ellipse, among other shapes. There may be a circular proximal border to account for the edge of the lens of the optic. The projection or projection aspect or extension or extension aspect is defined as a projection or protrusion outwardly beyond the perimeter of the circle of the lens of the optic, or edge of the optic, were ordinarily on a round optic there is no material or structure present. The use of an extension or projection here is clarifying; the combination of the extension and the distal aspect of the retention strut, when combined together, can be considered a retention strut entirely. For example, in some embodiments there is a transition within the overall retention strut such that the more proximal part of it is molded to the optic and wi der, and a second more distal part (either molded or secondarily attached to the more proximal aspect) that is thinner and engages the capsule. In some embodiments the entire optic is enlarged slightly to allow for the attachment of more than one retention strut. In some embodiments there is more than one projection from the edge of the optic for attachment of the distal aspect of the retention strut. As mentioned elsewhere, the retention strut may be of rectangular, triangular, square, oval, or generally trapezoidal shapes. It can be in these shapes but still less than 2 mm in thickness and height and approximately 3 mm in total length, including a bend if present. The retention is in some embodiments, but need not be a simple cylinder. When viewed from the side, instead of from the top looking down on the optic, the thickness of the projection aspect near the optic is approximately the thickness of the optic itself. The thickness of the projection is slightly less or slightly greater than the optic in some embodiments. The thickness is between 0.25 and 3 mm in some embodiments. The thickness of the projection is about 1 mm in some embodiments. The projection for attachment of the retention strut to the optic, when the attachment is not a plate haptic, extends to the maximum a distance of 7 mm and a minimum distance of 0.5 mm from the optic. More typically the extension is less than 5 mm but greater than 0.75 mm in outward length measured from the edge of the optic. The width of the extension aspect is 2mm in some embodiments, and slightly more or less in others. In some embodiments, the extension of the projection (or the more proximal part of the retention strut) is about 2 or 3 mm. This extension aspect from the optic has a hole such as an eyelet for attachment of the distal aspect of the retention strut secondarily during manufacture, in some embodiments. The extension can be molded around a different material to make up the distal aspect of the retention strut in some embodiments. The projection or extension aspect may be in the exact plane of the optic, or it may be directed slightly anterior or posterior to the optic. The advantages of a shape directed anterior slightly for example are that it allows for a movement or flexibility of the extension aspect and more distal retention strut together - with respect to the optic - and enhances secondary engagement of the distal end of the retention strut to the capsule especially when the more distal aspect of the retention strut is attached at, for example, a right angle to the projection or extension aspect. The projection or extension on the lens can accommodate, either by molding or secondary attachment during manufacture, a retention strut directed away from the projection in any direction including anterior, outward, or posterior. The distal end of the retention strut is directed back toward the optic in some embodiments. The middle aspect to the retention strut, from its attachment to the projection aspect from the optic, may exit the projection or extension aspect at any angle between -170 and +170 degrees. (Zero degrees here is directly outward in the plane of projection from the lens.) There is torsional flexibility is some embodiments. The retention shut itself when molded out of the same material as the extension aspect or when a two piece system projects outwardly and is tapered generally so the more distal aspect of the retention strut is narrower than the more proximal aspect. Of course, when a wedge is present, the distal end shows an eventual widening to allow for capture of the distal end of the retention strut and wedge together with the capsule. Thus, the shape of the retention strut as the view of the lens moves from optic outward can be variable, but in some embodiments the shape narrows from the attachment point toward the distal aspect. In some embodiments, what is described directly above as a projection from the lens is considered part of the retention strut itself, with a changing or variable shape. The attachment from the optic to the retention strut, or the projection off the lens for retention strut attachment, can be hinged for added flexibility in some embodiments. In one embodiment there is a projection from the lens in trapezoidal fashion of 3 mm and the midsection of the retention strut generally is joined at a right angle facing anteriorly and projecting 2mm anteriorly with a wedge. This embodiment has a flexibility at the juncture of the projection and the optic so when the anterior leaflet presses on the retention strut it moves slightly with respect to the optic and exerts gentle pressure on the internal aspect of the capsule. The lens is rotated to the correct position, and if needed, a small capsular hole is made which then allows for the wedge of the retention strut to engage the capsule by penetration. Other similar embodiments can be anticipated by a skilled artisan. The materials for the retention strut are flexible so that they do not break, but may bend, during insertion and manipulation within the eye, in some embodiments. Even when an expandable polymer is used, there is some flexibility of the retention strut in some examples.

Haptics are not designed to engage the anterior or posterior leaflet of the capsular bag. Traditional haptics are not used to engage the leaflets of the capsule in a penetrating fashion. Traditional haptics are not capable of engaging the capsule in a penetrating fashion, in that standard or even non-standard management of aphakia with an intraocular lens does not involve intentionally piercing a hole in the capsule and engaging the capsule with a haptic. Thus the novelty of the present invention involves the designed, or planned, use of a protrusion such as a retention strut that engages purposefully one or both leaflets of the capsular bag. Traditional haptics will not stabilize the intraocular lens via engaging the leaflets of the lens capsule. Furthermore, traditional haptics function by engaging the recess of the capsule, in other words haptics generally work in the plane of the potential space between the anterior and posterior leaflets of the capsule. The retention strut of the present invention, as part of an intraocular lens purposefully engages a leaflet of the capsule to reduce freedom of movement.

One embodiment has a retention strut that projects outwardly and has a bend directing the distal end retention strut anterior to the plane of the anterior surface of the intraocular lens. One embodiment has a retention strut that projects outwardly and anteriorly without a bend. Likewise, in one embodiment the retention strut projects outwardly and posteriorly without a bend. The intraocular lens in this embodiment may be a primary or a secondary intraocular lens. In one embodiment this intraocular lens with a retention strut has at least one of the following characteristics: multifocality, toric correction, presbyopic correction, and accommodating in nature.

In one embodiment, the intraocular lens with at least one retention strut and at least one haptic is primarily inserted into the capsular bag of an aphakic eye . The lens may have toric, multifocal, presbyopic, higher-order correction, wavefront, or accommodation characteristics. The nature of these lenses with toric, multifocal, presbyopic, wavefront, or accommodation characteristics requires very precise placement and centration. Haptic s do not universally adequately secure the intraocular lens in the most optimal position for long term best vision. If an intraocular lens of these types displaces by as much as 0.5 mm there can be less patient satisfaction. Likewise, if a lens with toric correction rotates away from planned placement, the visual results are suboptimal.

In one embodiment the intraocular lens with the retention strut is placed inside the capsular bag. The retention strut projects outwardly and anteriorly. Once placed, the retention strut puts slight pressure or points anteriorly onto the under or posterior surface of the anterior lens capsule leaflet. Then once the intraocular lens is rotated or positioned such that the intraocular lens is optimally located, a small sharp instrument (such as a small gauge needle tip, which can be bent or not, in any size between 18 gauge and 39 gauge) punctures the anterior capsular leaflet jut over the point where the retention strut touches the anterior capsule. The retention strut then, because of its design and position, then engages the anterior capsular leaflet in a penetrating fashion to help reduce degrees of freedom and lead to better visual results. It may be helpful or necessary to use a small instrument such as a Sinskey hook or other methods of surgical manipulation to help the retention strut engage through the hole in the capsule. A laser may create a hole in the capsule. The laser may be femtosecond, continuous wave, or other. Cautery, electrical energy, or heat is used to create the hole for the retention strut in some embodiments. Thus, herein described is a novel device with a retention strut that allows for securitization of an intraocular lens in the capsular bag with a retention strut that projects anterior to the optic and engages the anterior capsule. Recall, the anterior capsule has a capsulorhexis or capsulotomy or opening in the central anterior capsule to allow access to the capsular bag for intraocular lens placement. The retention strut engages the anterior capsule in this embodiment peripheral to said opening in the capsule. The new penetration, or new small hole, in the anterior capsule is made peripheral to the opening already present to allow penetration of the retention strut and better securitization of the lens.

Retention struts can tit with primary IOL's. Retention struts can fit with a lens with an aperture.

Retention struts can engage the posterior capsule, the anterior capsule or both.

The entire lens with the retention struts can be placed inside the capsular bag for in-the- bag fixation.

The retention strut may have a sharp end point that can penetrate the capsule without external energy.

The retention strut can be placed in a hole in the capsule made by a sharp instrument or laser.

The laser can be a femtosecond laser, or the hole can be made with a handheld fiberoptic cable that can create a hole in tissue such as a capsule. Thermal energy can create the hole in the capsule.

The retention strut may be part of a primary IOL, meaning it is inserted directly after cataract extraction. There need not be a secondary procedure.

A needle can create a hole in the capsule (i.e. 30g) for the retention strut. The retention strut can be molded as part of the lens. The angles of the strut, progression blocker, barb etc. are very variable. Anything that makes physiological sense will work.

The retention strut can be placed in position first, and the hole in the capsule can be made secondarily.

The retention strut can engage the capsule and hold position by friction. There can be friction of a strut anteriorly into the anterior capsule and posteriorly into the posterior capsule to engage the capsule and prevent lens movement by friction, not only by penetrating the capsule.

The retention strut can be bent down, or gently manipulated into position, once the premium IOL (or any IOL) is inserted, by hand, into a hole in the capsule to engage the lens.

The retention strut is amenable to use with any type of IOL— primary or secondary. It can be placed at time of cataract extraction, or later, in an eye with no lens or a pseudophakic eye. To provide further clarity, the following information is provided:

Basic eye dimensions: Diameter of anterior surface of cornea horizontal 1 1.75 mm; vertical 11 mm. Thickness of cornea: 0.5 mm to 0.7 mm. Thickness of sclera 0.3 mm to 2.0 mm. Depth of anterior chamber 2.5 mm to 4 mm. Volume of aqueous humor: 0.25 cc to 0.4 cc. Equatorial diameter of lens 7 to 10 mm. Distance across eye at the lane of the lens 12 mm to 20 mm. Dilated pupil diameter: 4 mm to 10 mm. Thickness of capsule range is 2 micrometers to 28 micrometers.

Typical dimensions of intraocular lens optics 3.0 mm to 7.5 mm. Foldable optics are 3.5 mm to 5.5 mm. The optic can be of thickness between 0.05 mm and 2 mm. Similar ranges are acceptable for the inventions of the optic with the retention strut. The optic is not round in some embodiments. When the terms radial are used and the optic is not round the direction radial is based on a circle drawn around the widest aspect of the lens. The optic has aspherical aspects, and/or an overall shape that varies from a circular round perimeter. Standard type haptic dimensions (or shorter or longer) apply to the use of a haptic in combination with a retention strut. The haptics can be as short as 3 mm or as long as 15 mm.

The retention strut can have any of variable dimension ratios and shapes: tapered or not tapered or complex tapers, the length can be from 1 mm to 10 mm. The minimum width (also considered external diameter if round) at time of insertion (completion of manufacturing) for the retention strut is 0.05 mm. The maximum width at completion of manufacturing is 3 mm. The Any value in between is acceptable for an embodiment of the retention strut. The retention strut is pictured as round in the figures. It need not be. It can be oval, oblong, triangular, square, rectangular, trapezoidal, or any other shape that allows for a functional connection between optic and capsule in an engaging by friction or a penetrating manner. The retention strut can have one or more bends. There are embodiments with attachments or molded protrusions that help secure (or allow for securitization or stabilization) the lens in the eye. The retention strut is s-shaped or irregularly shaped in some embodiments. The retention strut projects outwardly from the optic, but it need not be in one single plane, in a straight line, or directly radial. Some embodiments show a retention strut projecting generally straight outwardly radial from the optic. The optic size, plus haptic, plus retention strut tits inside the anterior segment of the human eye. The power of the optic in diopters is usually between +30 and - 30. Prism diopters are placed in some versions of the custom IOL described herein.

Although not shown, the retention strut can expand slowly over concentric zones. The retention strut could be modeled via a drawing with dotted lines showing expansion at different rates over different zones. The expansion of the retention and/or the optic can be initiated prior to implantation with heat or light, for example. The expansion of the retention strut and or optic and/or IOL generally could be initiated with a stimulating light once implanted inside the eye. Such an approach is considered herein and is an alternative to the expansion caused by the polymer's exposure to aqueous media. Adding light can control the swelling of the retention strut or lens polymer. The initiation of expansion can occur outside the eye in some embodiments. There is a set amount of time the surgeon has to place the novel IOL in some embodiments to ensure the proper expansion occurs when the retention strut is in place through the capsule leaflet(s).

The optic under discussion for the novel IOL has a bifocal or split type lens in some embodiments. For example, the add portion need not be in the center but is a shape different from round (it is half circle in some embodiments) and off center. See executive of Franklin type bifocal lenses to better understand one embodiment of the presbyopic correction configuration. Toricity and other optical aberrations including refractive power can still be corrected generally in these lenses.

An optical or laser imaging system is used for aligning the eye prior to any femtosecond or other laser correction, or in real time during placement of the novel IOL to ensure proper placement with respect to optical aberrations, astigmatism, and centration. or other laser cutting. Intra-operative aberrometry is used in some embodiments to assist with, monitor and/or confirm proper placement of the novel IOL.

Polymers for IOL: Several embodiments described above rely on the use of a hydrogel polymer. As and example a HEMA (2-Hydroxyethyl methacrylate) based copolymer consisting mainly of HEMA and DMA (N,N-dimethylacrylamide) can be formulated. In this family of polymers, the equilibrium water content can be tailored by controlling the relative ratio of HEMA to DMA. In addition, differential swelling characteristics can be imparted in the material by the introduction of a labile monomer in which a more polar group is created in the hydrogel after the deprotection of the chemical moiety. As an example we have used the tertiary butyl ester being converted to a carboxylic acid. Furthermore, higher water content formulations use the addition of a strengthening agent such as cyclohexy methacrylate (CH- MA) in some embodiments. To form a hydrogel network ethylene glycol dimethacrylate is used as the crosslinker. These formulations can be cured thermally using AIBN (Azobisisobutyronitrile). In some embodiments, the polymers proposed in the first family (HEMA-based hydrogels) will be rigid in the dry state and thus amenable to lathing of the intraocular lens. In other embodiments the intraocular lens can be cast molded. These polymers may be partially or fully hydrated to impart flexibility for delivery and placement in the eye.

Some embodiments use silicone based materials due to their good flexibility in the dry state. These silicone materials can include silicone hydrogels or silicone elastomers. Silicone hydrogels can be formed by copolymerization of polydimethylsiloxane macromonomers (M2Dx macromers), TRIS-MA [methacryloxypropyl tris(trimethyl-siloxy)silane] and DMA (N,N-dimethylacrylamide) which is polar and takes up water in the crosslinked polymer network. In addition, there are diphenylsiloxane derivatives of the M2Dx macromers that can be used to increase the refractive index of the polymer. The refractive index of these materials can also be tailored between 1.41 and 1.46. In the silicone hydrogel family, the dry material will be soft. As with the HEMA based hydrogels, differential swelling characteristics can be imparted in silicone hydrogels by the introduction of a labile monomer in which more polar groups are created in the hydrogel after the deprotection of the chemical moieties. These materials can be inserted dry or hydrated and allowed to reach their full swelling in the eye.

In some embodiments, polymer processing techniques can be utilized to preprogram in desired swelling. As an example, IOL or retention strut materials that expand more in the radial direction than in the longitudinal direction can be created. As an example, polymers that are partially polymerized and then stressed along the axis by pulling on both ends before undergoing complete polymerization show the tendency to expand greater in diameter than length. There are a variety of shape changing systems in the scientific literature that are based on prestressed crosslinked networks, and again the example above is not intended to be limiting.

In some embodiments a silicone elastomer may be used. Such materials can be formed from a first polymeric matrix composed of acetoxy terminated polydimethylsiloxanes that undergo crosslinking upon exposure to moisture. Within this matrix, a polymerizable silicone and a photoinitiator can be incorporated as a shape modulating compound that swells the material upon exposure to light. Such a system is disclosed in United States Patent 7,241 ,009, the entire disclosure of which is incorporated herein by reference. This same chemistry can be used to locally swell a retention strut. Variations herein contemplated and included are understood by one skilled in the art. No such devices could be found anywhere in the world.

Can interchange: capsulotomy fixated intraocular lens, transcapsular fixated intraocular lens, small- capsulotomy fixated intraocular lens, small, secondary capsulotomy fixated intraocular lens, retention strut - capsulotomy fixation, capsule perforating or capsule penetrating fixation system for intraocular lens, as a description, or as a name, or identifier for the novel retention strut intraocular lens.

Thin biological membrane: anterior capsule, posterior capsule, or both, or other. Made by an animal's body during development or life, generally. A thin biological membrane is less than 1 mm in thickness, generally. Fibrosis can increase the thickness in some instances. For clarity, a thin biological membrane is a type of thin membrane. The thin membrane is between 2 micrometers and 28 micrometers in thickness in some examples, or between 0.1 micrometers and 2000 micrometers in other examples. A 1 mm thick membrane is an acceptable representation of the thickness of the thin membrane in some examples. A thin sheet of polymer or other material can serve to represent a thin biological membrane in some examples.

Small capsulotomy holes are small penetrations in the anterior or posterior capsule or both that allow for the passage of a small cylindrical protrusion through them. The diameter is between 3 mm and 0.1 mm but is typically 1 mm in diameter or less. The small capsulotomy holes are marked with ink or cautery in some embodiments. There are other ways of marking the location as well. One method uses imaging and photography and reference points. The small capsulotomy holes are made outside the area of the primary IOL optic. The small holes are round or other shapes, or slits.

Small holes: The diameter is between 3 mm and 0.1 mm, and is approximately 1 mm in diameter or less in some embodiments. The holes can be, but do not need to be, exactly round. The holes can be a variety of shapes— regular or irregular. The holes are slits or small cuts in some embodiments of methods of use. The holes allow for penetration by a retention strut. The widest dimension of the hole is approximately 1 mm in some embodiments. The widest dimension is between 0.1 mm and 3 mm in some embodiments. The holes can be smaller or larger as needed for proper engagement with the retention strut.

Thin membrane: a sheet of material at least 3 mm in diameter if round, or 3 mm in one planar dimension by 2 mm in the second widest planar dimension if not round, with a thickness between 0.001 mm and 3 mm. This material is polymer based in some examples. It can be fabric, plastic, or cellulose in some examples.

Small holes in thin membrane: Holes described for "small holes" in '¾rin membrane". The holes are mechanically made, made by laser, or made by cautery, for example. Any method for the holes creation in the thin membrane applies. There is thus a material that the novel IOL with retention strut can engage, in air or aqueous media, that is novel. Other IOL's do not meet the criteria established for capture with a thin membrane Small capsulotomy holes (novel) may be made by a femtosecond laser, a YAG laser, an argon laser, a sharp instrument, heat, diathermy, radio frequency, a fiberoptic cable conveying continuous wave laser light focused at the tip or close to the tip, electrosurgery, electrocautery, thermocautery.

In some embodiments the creation of the small capsulotomy holes is made either with the novel instrument or through the novel instrument. In some embodiments the small capsulotomy holes are made with a laser and no mechanical entry of instruments into the eye is required

In some embodiments the optical aberrations of the eye are captured or measured prior to or during a surgical procedure with the novel IOL and novel instrument. All aberrations included in this application are considered, not limited to wave front, spherical, astigmatic, presbyopic, higher order aberrations, irregular astigmatism, coma, tilt, prism.

Femtosecond laser IOL refractive or optical correction is publicly discussed and not in and of itself technology being patented in this application. For example, this application does not claim using the laser to adjust the power of an IOL after it has been implanted in the eye, a noninvasive technique of shaping the refractive index that can be used on standard IOLs to correct for residual refractive errors, astigmatism, and higher order aberrations. It may even be used to produce multifocality on the lens after implantation. What is novel is a lens with a retention strut that can have optical characteristics adjusted in the eye. So, for instance, a lens of a certain biocompatible material is placed in the eye with the retention strut. The lens is placed in the optical axis. The lens can in some embodiments be treated with a femto- second laser to have its power adjusted.

Aspheric correction: the novel lens with the retention strut is aspheric in some embodiments.

The novel lens has any shape acceptable for a lens: biconvex, piano convex, positive meniscus, negative meniscus, piano concave, biconcave, spherical, spheric, and aspheric. The correction also includes irregular astigmatic correction. The novel intraocular lens with a retention strut can have anterior optic and posterior optic spherical and/or aspherical surfaces. Wave front correction and higher order correction is included in lens types for the novel IOL optic. The novel IOL optic is multifocal in some embodiments. There is a central aspect to the lens that has different power than the base lens in some embodiments. The lens corrects for presbyopia in some embodiments. The lens artificially creates a pupil in some embodiments. The lens accommodates in some embodiments. The accommodation is a function of movement based on the location of the secondary novel lens anterior to the primary IOL coupled with ciliary muscle activity in some embodiments.

Eye wall can be sclera or cornea. The instrument can be placed through the sclera or cornea. The incision is self sealing.

C-loop open: A haptic used on a traditional intraocular lens, the distal aspect has a loop such that the iteration with the capsule or sulcus is against the loop aspect, not a straight pointed end of a protrusion from the optic (as in the current invention).

Any A- constant. A constants are used in calculating an IOL power for implantation. The constant is a theoretical value that relates the lens power to axial length and keratometry, it is not expressed in units and is specific to the design of the IOL and its intended location and orientation within the eye. The novel IOL can have any A constant, including A constants seen for current IOLs.

Intraocular: Inside the eye. Surgical access is required to place an intraocular lens inside the eye.

IOL: intraocular lens. A lens that is biocompatible and implanted inside the eye. An artificial lens for the eye.

UV blocking, the novel lens described herein has UV and blue light blocking characteristics in some embodiments.

Angle theta in 5300 is based on an angle from the optic in either direction, and is between 90 degrees or greater and 0 degrees from the plane of the optic.

Straight haptic: there are no straight, thin haptic, haptics on current IOLs or historically— excluding plate haptics and wide straight haptics that have distal ends that interact in the recess of the capsule or sulcus. A thin protrusion straight haptic, as described herein, can in some embodiments be considered a retention strut. The straight haptic itself is novel. A straight haptic projecting from an intraocular lens is an invention described herein.

This protrusion: diameter less than 2 mm or width less than 2 mm if not round. End of haptic is straight and penetrates tissue as opposed to putting radial pressure on the recess of the capsule.

Radial projection means straight away from the IOL, but the projection may be pointed posteriorly or anteriorly, in some embodiments, radial projection can be, but need not be in the plane of the optic. A design where the projection of the retention strut is within 45 degrees of the radial is considered radial projection for the purposes of the invention, as it is feasible in some embodiments that a projection off-radial can still accomplish the fixation by penetration of the capsular leaflet or leaflets. Strut: A strut is a structural component designed to resist longitudinal compression. Struts provide outwards-facing support in their lengthwise direction, which can be used to keep two other components separate, performing the opposite function of a tie. They are commonly used in architecture and engineering. The retention strut helps secure the novel IOL in an outwards facing direction in some embodiments.

Tie: A tie, structural tie, or strap, is a structural component designed to resist tension. It is the opposite of a strut or column, which is designed to resist compression. Ties may be made of any tension resisting material. The retention strut helps secure the novel IOL in inwards facing direction, resisting forces pushing the novel IOL toward the direction 180 degrees from the retention strut, in some embodiments.

The retention strut also prevents side to side movement (translation) of the optic at the insertion point once the retention strut is placed through the membrane. There would be rotational movement about the point as an axis, but that would be controlled by a second strut or haptic on the IOL. The key for the retention strut can be simple control of movement of the optic in the plane of the capsule at or near the penetration by the retention strut in the small capsulotomy.

For the purposes of this invention and naming of the capsular retention strut, also called a retention strut, the retention strut has either strut- and/or tie- like characteristics, or otherwise motion stabilizing characteristics that allow for s decrease in the range of motion about a point. One retention strut alone does allow for rotation of the entire IOL about the axis of the point at the penetration of the capsule, and even with expansion to tighten the fit through the small capsulotomy, does not, in all embodiments, alone stabilize the IOL sufficiently. Combined with another retention strut, or a standard haptic, the novel IOL is secured. It is an invention described herein to secure an IOL with a single retention strut and a second stabilizing protrusion to secure the IOL in position. The single retention strut can be a generally straight haptic.

For the purposes of this invention and naming of the capsular retention strut, also called a retention strut, the protrusion form the optic ensures a stabilized position during and following placement of the lens in the eye. The aspects of the retention strut that are important are that it 1) when placed helps join the intraocular lens to the capsule; 2) once placed, and healed in place, or expanded by aqueous media to engage the tissue, prevents movement of the optic in the direction away from the strut or toward it or both. Alternatively, the retention strut simply joins the IOL in a manner that combined with another retention strut or haptic the IOL is secured in the eye. The joint at the optic is in some embodiments the critical aspect of the retention strut preventing movement in the direction of the strut, which accomplishes the task of stabilization when combined with another aspect of the intraocular lens such as another retention strut or a haptic. The approach and the method are also referred to as transcapsular stabilization for an IOL or of an IOL.

The retention strut is a generally straight protrusion from an optic of an intraocular lens.

Many embellishments are permitted to the retention strut, but if it is capable of securing the optic to the capsule of an eye in a penetrating manner than it is claimed and considered herein. Many variations exist, all of which cannot be named. For instance a small s-bend in the retention strut will not prevent it from performing its purpose of engaging the capsule in a penetrating manner, and it is claimed and covered herein. A small loop at the tip may not prevent placement, and is claimed herein.

The retention strut interacts with a membrane like structure to help stabilize an optical lens.

Optical axis of lens: a line passing through the center of curvature of a lens or spherical mirror and parallel to the axis of symmetry

Optical axis of eye: The line connecting the anterior and the posterior poles of the eye . No drawings are to scale. The invention is designed for use in a human eye. The range of dimensions of a human eye are well known, and the devices depicted and discussed can utilize dimensions typical for surgical instrument and implants in ophthalmology.

A thin biological membrane like structure includes the lens capsule.

Lens capsule: The lens capsule is a smooth, transparent basement membrane that completely surrounds the lens. The capsule is elastic and is composed of collagen. It is synthesized by the lens epithelium and its main components are Type IV collagen and sulfated glycosamrnoglycans (GAGs). The capsule is very elastic and so causes the lens to assume a more globular shape when not under the tension of the zonular fibers, which connect the lens capsule to the ciHary body. The capsule varies from 2 to 28 micrometers in thickness, being thickest near the equator and thinnest near the posterior pole. The lens capsule may be involved with the higher anterior curvature than posterior of the lens. Embodiments of the invention accommodate any fibrotic changes to the capsule and any secondary lens tissue left inside the capsule after cataract surgery

Bore, internal bore, passageway, lumen, cannula: These terms have in some descriptions inter-related meanings and can be synonymous. The characteristic described here is that there is an internal longitudinally open space that connects the proximal and distal aspects of the instrument for passage of any object or material selected from the group including an intraocular lens, a novel intraocular lens with a retention strut, infusion fluid, fluid with antibiotic, an instrument that helps advance an intraocular lens, an instrument with a pick and or forceps and/or jaws, an instrument that can manipulate a lens in an eye, and an instrument that can create a small capsulotomy hole, an instrument that can remove an IOL from an eye. The bore, internal bore, passageway, lumen, and/or cannula typically open at the distal aspect of the instrument or within 10 mm of the distal tip of the instrument. The proximal opening is further from the distal aspect of the instrument that contains the bore, internal bore, passageway, lumen, or cannula and is typically with 20 mm or more of the distal tip of the instrument.

Passageways can be called a lumen, an internal bore, and cannula.

Cannula: a tube that can be inserted into the body (eye in this discussion)

Proximal: situated nearer to the center of the body or the point of attachment in general. For the intraocular lens, proximal with regard to the retention strut refers to closer to the optic or point of attachment of the retention strut the optic, in some embodiments it is 180 degrees from the far tip of the retention strut. For the surgical instrument for the insertion of the novel lens in the eye, proximal is closer to the aspect of the device the surgeon holds or guides (the operative end of the device) and is approximately 180 degrees from the distal, or far end of the instrument, also called the surgical aspect of the instrument.

Distal: situated away from the center of the body or from the point of attachment. In this application distal for the surgical instrument means the aspect farthest from the surgeon. It can also be referred to as the surgical end of the instrument. It is the aspect that enters the eye or toward that direction. Regarding the novel intraocular lens, the distal aspect is away from the optic. Approximately 180 degrees from the distal is the proximal direction. The word approximate is used because bends or curves are permitted in the structure of the retention strut.

Operative end: The aspect of the insertion instrument that is closer to the surgeon and held by the surgeon's hands. The direction toward the operative end can be called toward the proximal end of the instrument.

Surgical end: The aspect of the instrument that enters the eye, cuts the eye, places the IOL in the eye, makes the small capsulotomy, manipulates the IOL, or otherwise enters the eye. The direction toward the surgical end of the instrument is distal, away from the surgeon and the site the surgeon grasps.

Blade: A sharp device at the distal end of the surgical instrument; a keratome, a keratotomy blade. Can cut the sclera, can cut the cornea, to create an incision in the eye wall. Can partially cut the eye wall, or complete the cut initiated by another instrument. Can make the incision a very specific size, such as 2.3 mm, 3.2 mm, 1.8 mm, or other. The blade on the instrument enlarges a small incision already made or started by another blade in some embodiments. The incision is on the sclera or peripheral cornea. The blade is stainless steel, ceramic, diamond, or other latest sharp cutting material.

Capture system: Refers to the capture of the anterior capsule by the retention strut. Approaches and device characteristics: simple placement of retention strut through the capsule, simple placement of an expandable retention strut through capsule. (Capsule means anterior leaflet, posterior leaflet, or both; can include residual lens material such as cortex; lens fibrosis may be present; status post YAG capsulotomy is seen in some embodiments. There is typically and anterior capsulotomy or capsular rhexis already performed.)

Wedge capture, wedge, and wedge attachment, wedge system: A distal widening of the retention strut that captures the capsule from the posterior side once placed through the capsule leaflet(s). The wedge may be expandable. The wedge has a secondary taper after the widening seen at the distal protrusion in some embodiments. The wedge engages the capsule or a membrane such that it is difficult to pull the wedge back through the way it (as part of the retention strut) came. It can be considered a variation on a snap-fit process. The wedge fits through the small hole, with a leading point in some embodiments. The wedge aspect widens, and the widest part then makes retraction back through the small capsulotomy hole more difficult to secure the retention strut (and IOL). The wedge has a flat back to aid in the retention of the strut. The wedge expands in aqueous in some embodiments. The wedge is many different sizes in different embodiments. The wedge is 2 mm at its widest in one embodiment. It is 1 mm at its widest in one embodiment. The wedge can be three dimensional and round. The wedge is also in one plane, or two intersecting planes in different embodiments. The wedge has a proximal shape more like a barb in some embodiments. The wedge captures the membrane or lens capsule.

Wedge, barbs, progression blocker, protrusions on the retention strut: these protrusions can emanate with a tilt, these aspects do not need to be exactly as drawn in the figures. For example, the proximal aspect of the wedge can be oriented in the plane of the optic as opposed to the plane 90 degrees to the retention strut. The same can be said for other protrusions such as the progression blocker. There are many variations for the retention strut, its angle of projection from the optic, its direction, and the tilt or angle of projection or orientation for the retention strut protrusions including wedges, barbs, and progression blockers. The protrusions need not be symmetric. In some embodiments the asymmetric nature of the protrusions is a characteristic conferring additional novelty, as haptics are generally symmetric. Barbs: a sharp projection near the end of the retention strut, angled away from the main point or leading aspect of the retention strut so as to make extraction difficult.

Arrow design capture: The wedge has an arrowhead design in some embodiments. The pointed end of the retention strut has a wedge shape. The appearance is similar to an arrow head.

Barb capture system: The retention strut has a barb or barbs to capture the capsule Capsular bag capture system: the retention strut engages the capsular bag making the attached IOL secure in its intraocular position. The system is unique because the capsule is penetrated, engaged with friction, or otherwise engaged in a penetrating manner. The system is capable of engaging a membrane, or tough thin structure as a surrogate for the capsule in a secure manner.

Foldable: The intraocular lens is capable of being passed through a small incision in the eye, and/or through a lens insertion instrument. The optic is flexible and can be folded and or rolled in some embodiments. If the lens is very small folding is not required. The lens is very thin in some embodiments and can be rolled or folded either by the surgeon or assistant or during manufacturing. The lens may expand upon exposure to aqueous fluid or water.

Eyelets: Small holes in either the optic, haptic- optic junction, and/or on the haptic of an IOL that the retention strut can pass through and then engage. Small holes, molded in to an IOL or capsular tension ring, or created through multiple piece manufacture. The novel IOL thus interacts by engagement of the retention strut through the eyelets with the primary IOL as a method to secure the secondary lens. In some embodiments, the capsule also must be perforated or penetrated. The combination of the novel IOL with a retention strut and a device; the device with an eyelet is an invention. In some embodiments the capsule does not need to be penetrated for the engagement of retention strut and device with eyelet. The eyelet holes are round, square, triangular or another shape. The eyelets are as small as 1 mm or less in widest diameter, or as large as 3 mm or more in widest diameter. The eyelets are generally between 1 and 3 mm in diameter at the widest point. The eyelet is in the optic, at the optic haptic junction, or part of the haptic depending on the embodiment. The eyelet is on a protrusion from a capsular tension ring or on the perimeter of the ring. In some embodiments there is engagement of the eyelet and penetration through the capsule. In such a case, the small capsulotomy is made by a separate instrument in one embodiment. The retention strut has enough stiffness and sharpness to penetrate the capsule, with or without the eyelet, in some embodiments. A capsular tension ring also has an eyelet for the novel IOL's retention strut. The retention strut engages the small hole in the other primary intraocular device that has the eyelet. The eyelet is a complete small hole, it need not be round, for interaction with the retention strut. The eyelet lias a diameter between 0.5 mm and 3 mm. A primary IOL has an eyelet designed for an eventual dual lens system. The primary IOL can have an eyelet at one of several locations. A primary IOL can have multiple eyelets. In addition to IOL, and capsular tension ring, an alternative polymeric support structure that is secured in the eye has eyelets for the novel IOL in some embodiments. This third type of polymeric structure can be used when there is no capsule.

Rollable: The intraocular lens is capable of being passed through a small incision in the eye, and/or through a lens insertion instrument. The optic is flexible and can be rolled or folded in some embodiments. If the lens is very small rolling is not required. The lens is very thin in some embodiments and can be rolled either by the surgeon or assistant or during manufacturing. The lens may expand upon exposure to aqueous fluid or water.

Taco fold: the lens is folded in half.

Self folding: The novel lens with the retention struts can be folded by placing the lens into a specially designed inserter that, with or without special grooves, folds when advanced in the lumen.

The degree of freedom of a system can be viewed as the minimum number of coordinates required to specify a configuration. Applying this definition, we have:

For a single particle in a plane two coordinates define its location so it has two degrees of freedom; A single particle in space requires three coordinates so it has three degrees of freedom;

Two particles in space have a combined six degrees of freedom; If two particles in space are constrained to maintain a constant distance from each other, then the six coordinates must satisfy a single constraint equation defined by the distance formula. This reduces the degree of freedom of the system to five, because the distance formula can be used to solve for the remaining coordinate once the other five are specified. Degrees of freedom, and movements possible for a point or an intraocular lens:

Translation:

Moving up and down (heaving);

Moving left and right (swaying);

Moving forward and backward (surging);

Rotation

Tilts forward and backward (pitching);

Swivels left and right (yawing);

Pivots side to side (rolling). The discussion on movement is related to intraocular lens (generally) on top of a lens capsule in an apha c eye, on top of a primary IOL in the anterior segment, or on a thin membrane. The said intraocular lens can move in multiple directions and manners when placed in front of (anterior to) the lens capsule or an IOL, or (as an example for description, but any manner of placement is acceptable) on top of a thin membrane held in the horizontal plane. There is can be movement of the entire intraocular lens anteriorly or posteriorly (there may be some situations where depending on orientation the intraocular lens is in a situation when it can still move somewhat posteriorly as in juxta-positioning as opposed to direct alignment), however there can be some mechanical blockage posteriorly in the situation thus described. Nevertheless, there can be movement of the optic in the inferior direction and superior direction, and in the temporal or nasal direction, as well as twists, rotations, swivels, and pivots. For a thin membrane held horizontal in space, an IOL on its top can move upward, downward (depending on alignment and flexibility, pliability, stiffness, weaknesses, openings, irregularities of the membrane or capsule in some embodiments), plus forward, backward, left and right motion. The lens can also twist, rotate, swivel, and pivot. The movement (or degrees of freedom) of the intraocular lens, for the purposes here a novel retention strut based intraocular lens are limited, or reduced, by the placement of a retention strut based lens with the retention strut through the membrane. In some embodiments two or more degrees of freedom are limited or reduced. In some embodiments of the lens, three degrees of freedom are limited or reduced.

In one embodiment the retention strut by engaging the thin membrane, limits the freedom of movement of the entire optic in the plane of the optic in the direction 90 degrees from the site of retention strut projection. The entire lens is no longer free to move in those directions (right and left, for example when looking directly at the retention strut protruding from the optic. Similarly, when the retention strut is placed through the thin membrane, the optic is placed in close contact with the thin membrane at the site of penetration or engagement. The optic is no longer free to move in the direction of the protruding retention strut. When embodiments of the retention strut are considered with attachments such as progression blockers and/or wedges and/or barbs, the same and in some embodiments, additional degrees of freedom or ability for the lens to move are limited and/or restricted. Thus, the retention strut based IOL (or retention strut connected to a lens suitable for intraocular use or to an artificial lens for the eye) when placed as described with the retention strut penetrating a small hole in a thin membrane, will limit freedom of movement of the said IOL. Retention: holding in place, controlling at least one of the six degrees of freedom. The retention strut limits the freedom of the secondary IOL with the retention strut from moving in at least one plane or manner, it may control or limit more than one. In combination with the mechanical presence of the capsule and/or IOL, and possibly other retention strut or haptic, multiple degrees of freedom are controlled for. The retention strut in one embodiment controls any one of the degrees of freedom selected from the six degrees of freedom described herein.

Securitization, stabilization: Holding in place, securing in place, decreasing freedom to move, stabilizing. Limiting by at least one, possibly more, the freedom to move of the six movements described herein. Refers primarily to an IOL in an eye, for example, stabilizing the novel IOL with retention strut in the eye. Preventing dislocation of the novel IOL, preventing dislocation of the primary IOL and secondary IOL combined.

Novel IOL: intraocular lens with at least one retention strut.

Capture: engaging the capsule, or eyelet by the retention strut. Also involves combination with a haptic in some embodiments. Leads to stabilization.

Coapting: to fasten together, cause to adhere, bring together. The retention strut helps coapt the lens to the capsule, expandable polymers can help, fibrosis can help. Coaptation: fastened or being fastened together.

"In place": Holding the novel IOL in position.

Capsular tension ring: Polymeric ring that is placed in the capsular bag to help maintain the positioning and strength of the capsular bag. Used in cataract surgery, especially with capsular instability. Capsular tension rings are compatible with novel IOL.

Figures are not to scale.

All ranges of lengths, widths, diameters that are acceptable for a surgical instrument are possible embodiments. The requirement is that the instrument can accomplish the task in the eye of a mammal, preferably human.

The novel lens power may be any dipodic power or any combination thereof.

Bend in retention strut: Change in direction of the retention strut as one progresses from proximal aspect to the distal. The retention strut need not be straight in any or all planes. The retention strut may have one, two, or three bends, in the same or different planes. The retention strut at the distal end is designed to penetrate a membrane and secure the lens in position. The course of the retention strut from optic to distal end has one or more bends in some embodiments.

Pin to prevent slippage or movement of secondary IOL: A protrusion on the optic to help limit movement of the secondary lens. It may touch or engage the optic of the primary IOL, its own small capsulotomy (in which case it can be considered a modified retention strut in some embodiments), or the capsule itself. It points from the optic or haptic or retention strut posteriorly in some embodiments. It helps "pin" the lens in place.

Pin to prevent movement of IOL with arrow type configuration. Different pins to prevent secondary IOL movement can have different configuration. The key is a pin touches another structure to help stabilize the secondary IOL to which it is attached.

Any sharpness of pin is described

Vitreous cavity: aspect of posterior segment where vitreous gel is found.

Optic for novel lens showing central support pin to maintain a fixed inter-lens distance when used in piggy back configuration. The pin may also have a role in maintaining the secondary IOL a set distance from the primary IOL. This support pin is central in some embodiments, peripheral on the optic in others. There can be one or more. Maintaining a set distance between the secondary IOL and the primary IOL is important when correcting refractive error. An invention contained herein is any secondary IOL with a support pin for maintain distance between IOLs.

Piggyback IOLs: One lens in front of another inside an eye.

Intraocular lens: Lens placed in the eye to focus light on the retina.

Spherical power:

Cautery temperatures range from 220 degrees Fahrenheit to 5000 degrees Fahrenheit. Temperature is 2000 degrees Fahrenheit in one embodiment.

Tip sizes for the cautery instrument cover the range needed to place the instrument through a corneal incision of 3.2 mm in length to as small as going through a 0.5 mm lumen. In one embodiment the lumen is 1 mm. In another, the lumen is 2 mm in internal diameter.

Toric IOLs correct astigmatism.

Cylindrical power corrects astigmatism.

Customized lens power: power determined on a per patient basis, and the lens is specially designed and/or placed for the patient. For instance, a toric IOL must be placed in the proper visual axis.

Angle between 40 degrees anterior and 40 degrees posterior, preferred at around 10 degrees anterior to vault sulcus fixated IOL slightly posterior to avoid iris capture.

Retention strut can have multiple configurations and designs, some of which are described herein, all alterations and configurations being covered by this application. Posterior chamber of anterior segment: behind the iris; the location for most IOL placement, whether it be in the capsular bag, or in the ciliary sulcus. In front of the posterior capsular leaflets.

Anterior segment: The front 1/3 of the eye. Includes anterior chamber (Back of cornea to iris) where the instrument enters the eye, and the posterior chamber where IOL's typically are placed. There is anterior chamber IOL technology, and although the novel lens can be used by the surgeon in alternative ways in some situations, the purposes here are generally directed at posterior chamber IOL fixation.

Posterior segment: The Back 2/3 of the eye. The posterior segment begins behind the posterior capsule. It includes the vitreous, choroid, retina, and optic disc. The pars plana is in the posterior segment. There are embodiments where pars plana approaches can be utilized for this technology, although typically the anterior approach is utilized.

In-the-bag fixation; in-the-bag: The placement of an IOL is in the bag when the standard haptics are between the anterior and posterior capsular leaflets. The optic is also between the leaflets, except at the spot of the capsulorhexis or large-type central capsulotomy used for access to the bag and placement of the haptics and optic through the capsulotomy or rhexis for in-the-bag placement. The haptics typically engage the recess in the back or the capsular recess. In-the-bag fixated IOL's are often not centrally aligned, and can move or partially dislocate in the bag. The new technology (novel retention strut IOL) interacts with capsular fixated primary IOL's in some embodiments. The novel IOL can be placed in the visual axis. The optic is anterior to the primary IOL.

Capsulorhexis: Capsulorhexis is a technique used to remove the lens capsule during cataract surgery. It generally refers to removal of a part of the anterior lens capsule, but in situations like a developmental cataract a part of the posterior capsule is also removed by a similar technique. The method can also be called Continuous Curvilinear Capsulorhexis' (CCC), the term describing the exact surgical technique. Shear and stretch forces are used. For the purposes of this invention, capsulorhexis can be the exact procedure that leads to the removal of a section of anterior capsule from the eye. Likewise, a femto-second laser can open up section of the anterior capsule. A needle can also cut open a section, here termed can-opener capsulotomy. The capsulorhexis site refers in this application to the opening of the capsule that provided access to the cataract for removal and the access to the capsular bag for placement of an in-the-bag IOL. In order to remove a cataract with modern techniques, the capsule of the lens must be opened. Aphakic: no lens in the eye. Pseudophakia: An artificial plastic lens is inside the eye. An intraocular lens is inside the eye.

(The novel retention struts combined with an optic described herein are used for the treatment of surgical aphakia as well as pseudophakia, in certain embodiments.)

Primary IOL: The IOL that is placed at the time of cataract surgery.

Secondary intraocular lens: An IOL that is placed secondarily, on a separate occasion. The eye may be left aphakic at the time of cataract surgery, and then a secondary IOL is placed. Alternatively, a piggy-back IOL can be placed surgically in eye that already has a primary IOL. The piggy-back, second lens is a secondary IOL. Secondary IOL's are placed at a point in time after the surgical wound for a cataract removal has been closed. In many embodiments, the novel retention strut IOL is placed secondarily, either in an aphakic, or pseudophakic eye. The novel retention strut IOL is placed primarily in other embodiments.

Piggy back positioning; piggyback IOL: To correct a number of problems with a primary IOL, a useful method is to implant a piggyback IOL in the ciliary sulcus over the existing lens implant. Thus, a piggyback IOL sits in front of a primary IOL. Piggyback positioning is not new. A piggyback lens is one that has been placed after a first lens (which is typically in place in the back) is in the eye. Then, a secondary IOL is placed in the eye in fiont of the primary IOL. One key aspect to this invention is the method of securitization or stabilization in the eye. The novel IOL uses a retention strut, of which there are multiple variations, to penetrate the capsule and secure the secondary lens, often in piggyback fashion.

Dilated pupil: The pupil of the eye is larger than would be typically expected for the lighting situation. An eye can have a dilated pupil from pharmacologic agents. An eye can have a dilated pupil from trauma. An eye can have a dilated pupil from neurologic damage (3^rd nerve palsy, or ciliary nerve damage). The current novel IOL is typically place through a dilated pupil. One embodiment helps an eye with a traumatic or nerve problem as the source of the dilation by having an opaque aspect that creates an artificial pupil (functionally and in appearance from a distance).

Undilated pupil: A small pupil, or more typically an eye that does not have a dilated pupil.

Anterior end of retention strut may protrude slightly out of optic plane in some embodiments; proximal end of retention strut protrudes out of optic plane in some embodiments. The retention strut has aspects anterior to the optic plane in some embodiments.

The lens and/or optic and or retention struts are pliable in some embodiments, which helps for folding and to reduce breakage. In some embodiments, there is stiffness in one direction such as the direction alon the line of the retention strut, but it can bend if pressure is applied to the side. Thus, there are differential stiffnesses inherent to the retention strut in some embodiments. The manufacturing and gradation are novel to create this differential in stiffness.

A retention system for the optic end of the retention strut comprising simple molding around the retention strut. Regarding manufacturing, in some embodiments, the optic is molded around the proximal aspect of the retention strut. There are other manufacturing and design relationships for the optic/retention strut capture. Different embodiments of the invention use different capture systems. There are two and three-piece designs.

Retention strut accessories: Aspects of the retention strut that protrude from a basic cylindrical structure. The wedge, the progression blocker, the cap, the attachment system, barbs are all retention strut accessories. The retention strut also has bends, curves, and non-cylindrical shapes in some embodiments.

Centered IOL: An IOL is centered if the optical axis of the lens lines up with the visual axis of the eye (centration).

Decentered IOL: An IOL is decentered if the optical axis of the lens is different than the visual axis of the eye. An IOL can be decentered. An IOL can decenter.

Partially dislocated IOL: A partially dislocated IOL can still be in the capsular bag, its optic simply moved out of centration.

Laser: A laser is a device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation. Lasers differ from other sources of light because they emit light coherently. Spatial coherence allows a laser to be focused to a tight spot, enabling applications like laser cutting. Laser light can be used to create a small capsulotomy in this current invention.

Femtosecond laser: Temporal coherence can be used to produce pulses of light— as short as a femtosecond.

Argon laser: Can also refer to ion lasers, and other lasers that use gas in a tube. Krypton lasers are used for scientific research, or when krypton is mixed with argon, for creation of "white-light" lasers. These types of laser light can be used through fiberoptics to create a cut, or hole inside the eye. The laser can also be focused externally and create a hole in the capsule.

Yag laser: Nd:YAG (neodymium-doped yttrium aluminum garnet; Nd:Y3A15012) is a crystal that is used as a lasing medium for solid-state lasers. A Yag laser can make a cut in the capsule and in some embodiments is the approach to creating the small capsulotomy for use with the retention strut based lens. Continuous wave laser: A laser based on a continuous wave or continuous waveform (CW); an electromagnetic wave of constant amplitude and frequency.

Sharp instrument: An instrument that can cut tissue. Can cut ^'the sclera, cornea, or lens capsule.

Cautery: An agent used to burn, sear, or destroy tissue. The capsule can be cauterized to create a small capsulotomy. This step has been reduced to practice using a hand held thermocautery unit.

Thermocautery: Using heat to disrupt tissue, or cauterize. The application in this invention is a microcautery device that is used inside the eye to create a small capsulotomy. It fits through the insertion instrument in some embodiments.

Electrocautery: refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction.

Electrosurgery: electrosurgery is a group of commonly used procedures that utilize the passage of high-frequency alternating electrical current through living tissue to achieve varying degrees of tissue destruction. Different forms of electrosurgery include electrocoagulation, electrofulguration, electrodessication, and electrosection. Electrosurgery produces electromagnetic interference. For the purposes of this invention, electrosurgical instruments can be used to make a small capsulotomy. Electrosurgery, can be substituted in figures, where applicable. An electrosurgical instrument is utilized in some embodiments: it is passed through the insertion instrument into the eye, and a small capsulotomy hole is made.

Fiberoptic cable: An optical fiber is a flexible, transparent fiber made of high quality extruded glass (silica) or plastic, slightly thicker than a human hair. It can function as a waveguide, or "light pipe" to transmit light between the two ends of the fiber. In this invention, a fiberoptic cable can be passed through the insertion instrument to use laser to create a small capsulotomy. Focusing at the point of exit of the light, or within several mm is an important aspect of the invention thus preventing posterior segment damage from laser light. An embodiment of the invention herein uses a fiber optic to transmit light through an instrument with the focusing of the laser light near (within several mm) of the distal tip, to create a small capsulotomy.

Heat source: A source of energy for the application of heat to the capsule for the creation of a small capsulotomy.

Battery powered: Batteries power the energy source for the laser or cautery or electrosurgery, or any device passed though the novel insertion instrument. Electricity powered: Electricity (alternating current, direct current) powers the laser or cautery devices. Electricity powers the energy source for the laser or cautery or electrosurgery, or any device passed though the novel insertion instrument. The instrument may use batteries or electricity from a wall outlet or alternative source of electricity such as a generator.

Well positioned IOL: An IOL that has the lens axis in the eye's visual axis or close enough. There is minimal tilt, and no patient symptoms related to the IOL that are due to placement or positioning.

Off center primary IOL: An IOL that is dislocated, otherwise displaced, or not in a position that is well-positioned.

Novel fixation system: The capsulotomy fixated IOL, the retention strut based lens stabilization approach described herein.

Straight haptic: Not seen commercially at this time. Novel to this invention, can be considered a retention strut in some embodiments or descriptions. A straight protrusion out of the IOL optic. A haptic has a loop, or bend, or wider based iteration or distal endpoint of the haptic. A plate haptic is not a straight haptic in this discussion. A straight haptic is a small cylindrical protrusion that projects outwardly. Such a protrusion is ineffective at engaging the recess of the capsule, and is not seen for secondary lenses. A straight haptic that is capable of penetrating a thin membrane, or engaging by friction , for fixation can be considered a retention strut in some embodiments.

Pin: A term used in this application that can describe a method of isolating, or securing a device in the eye. It may refer to a protrusion of an optic or a retention strut. The term can be used to describe the process of securing one item to another "pinning", or can be used to describe the protrusion directly. Rivet, can also be used to describe the method a retention strut attaches to the capsule. Rivets are permanent mechanical fasteners. In some embodiments, it is acceptable to refer to the retention strut as a permanent mechanical fastener. The novel IOL is fastened to the capsule.

Capsular fixation attachment

One piece IOL: An IOL molded from one material, all one piece.

Two piece IOL: An IOL with two distinct parts that are placed together and attached during manufacturing.

Three piece IOL: An IOL with three distinct parts that are placed together and attached during manufacturing.

Hydrogel: Used as material for the retention strut and/or optic, and or haptic, and/or other aspects of the novel intraocular lens. Hydrogel is a network of polymer chains that are hydrophilic. In some embodiments, water is the dispersion medium. Hydrogels can absorb water. There are natural or synthetic polymers. Hydrogels can possess a degree of flexibility very similar to natural tissue, due to their significant water content. Hydrogels are used in some embodiments of the inventions described herein.

Expandable, Expandable hydrogel: A polymeric material (typical hydrogel) that is able to bind or encompass water molecules. The base polymers can be adjusted to control the rates of expansion or swelling, on exposure to water. Hydrogel: Gel in which the swelling agent is water. The network component of a hydrogel is usually a polymer network. A hydrogel in which the network component is a colloidal network may be referred to as an aquagel.

Gel: Nonfluid colloidal network or polymer network that is expanded throughout its whole volume by a fluid. A gel has a finite, usually rather small, yield stress. A gel can contain:

(1) a covalent polymer network, e.g., a network formed by crosslin ng polymer chains or by nonlinear polymerization;

(ii) a polymer network formed through the physical aggregation of polymer chains, caused by hydrogen bonds, crystallization, helix formation, complexation, etc., that results in regions of local order acting as the network junction points. The resulting swollen network may be termed a "thermoreversible gel" if the regions of local order are thermally reversible;

(iii) a polymer network formed through glassy junction points, e.g., one based on block copolymers. If the junction points are thermally reversible glassy domains, the resulting swollen network may also be termed a thermoreversible gel;

(iv) lamellar structures including mesophases defines lamellar crystal and

mesophase, e.g., soap gels, phospholipids, and clays;

(v) particulate disordered structures, e.g., a flocculent precipitate usually consisting of particles with large geometrical anisotropy, such as in V205 gels and globular or fibrillar protein gels.

Suitable polymers for the lens and/or retention strut (they may be different materials) include, for example, biocompatible polymers, poly(methyl methacrylate) ("PMMA"), poly(ethylene-co-vinyl alcohol) ("EVAL"), poly(butyl methacrylate) ("PBMA"), polyglycolic acid ("PGA"), poly(L-lactic acid) ("PLLA"), woven polymers, silicones, hydrogels, copolymers and blends thereof, as well as various nanomaterials such as carbon nanotubes and the like, or other polymers used for biocompatible implants.

The retention strut is expandable by thermoreversible gelling, or utilizes a thermoreversibe gel to enhance implantation in some embodiments. For example, the retention strut has a greater stiffness in one embodiment that eases placement through the small capsulotomy holes, and once placed in the environment of the body (at roughly 38 degrees F), the gel swells or otherwise changes to enhance positioning or performance. Alternative approaches such as more flexible structures being placed that change to less flexible is also an embodiment.

Implants: a device that is implanted and left in a mammal at the conclusion of surgery. The novel IOL is an implant.

Ring: A device that surrounds another. It is molded or secondarily attached depending on the embodiment. In some embodiments there is a ring around the retention strut at the proximal end to engage the optic.

Molded: The resin or non- final polymer is placed in a mold during manufacturing of the novel IOL.

Snap fit- like expansion system: The wedge can snap-fit in to the small capsulotomy holes in some embodiments. The wedge is forced gently in to place, and the proximal aspect of the wedge engages the capsule preventing release. There are snap fit attachments between retention strut and optic in some embodiments.

Capsular capture system: The novel IOL utilizes retention struts for capsular capture. In some embodiments the retention strut pins the optic in place. Pins can be defined as: a piece of solid material (as polymer here) used for fastening things together or as a support by which one thing may be suspended from another— here the novel IOL to the capsular bag.

Angle of Retention strut exit from optic: The retention strut emanates from the optic in different, planes, angles, and orientations depending on the embodiment. The functionality of the retention strut is the key aspect that effects the orientation. Different embodiments have aspects that emanate in different directions, have bends, emanate from the optic directly outward, posteriorly, anteriorly, off axis or in any manner consistent with pinning the optic to a thin membrane.

Ring system to secure retention strut: The retention strut is secured to the optic with a ring-based system in some embodiments.

C-Loop haptics: A haptic, there is a wide curve (similar to the radius of diameter of the optic) as the outward manifestation of the haptics farthest most protrusion. A retention strut feasibly has a loop at the outward aspect in some embodiments; however, the key for the retention strut is that it engages the capsule (or a membrane, or a thin planar structure, for instance less than 1 MM in thickness) in a manner that is piercing or is penetrating. A traditional C-loop haptic exerts resistance in the recess of the capsular bag or the sulcus to create a stabilizing effect.

The present invention provides distal features of protrusions (in some discussions the word haptic can apply) of intraocular lenses which serve to fixate the haptic, or protrusion through the posterior capsule and/or the anterior capsular of the capsular bag. The fibrosis process and procedure for effecting fibrosis further stabilizes the optic. The retention strut's engagement with the capsular bag, or thin membrane is a key aspect of fixation.

It is important that distal portions of haptic means be fixated in the periphery of the capsular bag between an anterior capsular remnant and the posterior capsule, and that such distal portions or features not move relative to pockets or tunnels defined by fibrosis about distal haptic features.

Resilient: able to recoil or spring back into shape after bending, stretching, or being compressed

For the purposes of clarification, the present invention describes a method for stabilizing an intraocular lens to a thin membrane, of thickness between 0.001 mm and 3 mm, using a projection that penetrates the membrane and limits movement in at least one degree of freedom.

Wide closed loop haptic: A wider distal curve in a loop haptic.

J Loop haptics: A slightly tighter curve distally of a loop haptic, typically open.

Opening in optic for strut attachment: A small hole is left in an optic at the time of manufacturing for secondary attachment of a retention strut. The hole in the optic is secondarily created in some embodiments,

Accommodative effect with ciliary muscle movement: The novel lens with retention strut provides changes in refractive power following ciliary muscle constriction in some embodiments.

Anterior end flush with Optic plane: The proximal aspect of the retention strut is flush in the anterior plane of the optic in some embodiments.

Retention system of separate double cylindrical hollow bore torus with shown ring like design: The retention strut is attached to the optic with a double ring structure in some embodiments. This structure is a separate piece in some embodiments. The novel retention strut based IOL has multiple pieces in some embodiments. The ring like structure is molded on the retention strut in some embodiments.

Molded with optic: the retention strut is molded to the optic in some embodiments.

Differential expansion rate with optic: The optic expands in some embodiments, not in others. The retention strut expands in some embodiments not in others. In some embodiments the different parts or aspects of the retention strut expand at different rates and in different ways depending on the polymeric composition.

Wedge type capture system for retention ^'strut: the wedge system enhances the ability for the retention strut to engage a thin membrane.

Double torus around distal end of retention strut: There are structures or attributes of the distal retention strut that enable enhanced engagement with thin membranes.

Molded for two piece attachment of retention strut: the proximal aspect of the retention strut is molded to the optic in certain embodiments. Allowing space for expansion within the mold is an aspect of this invention. In one embodiment of the present invention, an optic that can accommodate stress at the retention strut junction is provided. Differential expansion to limit stress at the optic retention strut junction is an embodiment.

Gradient variable expandable hydrogel: A variable expansile retention strut, or haptic, is an embodiment of the invention.

Gradient-index (GRIN) lenses have a gradual variation of the refractive index of a material. Such variations can be used to produce lenses with flat surfaces, or lenses that do not have the aberrations typical of traditional spherical lenses. Gradient-index lenses may have a refraction gradient that is spherical, axial, or radial. The optic of the novel IOL may be a GRIN lens.

Retention "T" for optic end of retention strut: the retention strut's proximal end terminates in a "t" like shape to enhance attachment to the optic; true for molded and other types of attachment.

Variable expandable retention strut: the expansion may be regular, irregular, graded, quick (seconds), medium fast (minutes), or slow (hours), the expansion may be in a gradient, or in a linear or non linear manner.

Variant not shown has haptic also expansile whether one piece, two piece or three piece.

Novel secondary IOL with single retention strut and one haptic in front of primary lens is an embodiment of the invention.

Securitization anterior to capsule: Location where the novel IOL is secured in some embodiments.

Use can be in aphakic eye, at time of cataract surgery or secondarily.

If used at primary surgery, one haptic can be in the bag, the retention strut can penetrate capsule from anterior location for fixation.

Secondary IOL or the novel IOL with retention struts optic size can be equal to, smaller, or larger than primary IOL optic size. Secondary IOL or the novel IOL with retention struts optic size can. be between 2 and 8 mm in diameters.

Capsular tension ring (not shown): The novel IOL with retention strut is used with a capsular retention strut in some embodiments.

Double barrel: an instrument with two barrels, bores, passageways, lumens, or cannulas mounted side by side in a surgical instrument that is used to place an intraocular lens in an eye, the sizes of the lumens are different in different embodiments.

Single barrel: Single passageway instrument.

Triple barrel: An instrument with three barrels, bores, passageways, lumens, or cannulas contained within one surgical instrument that is used to place an intraocular lens in an eye. The sizes of the lumens are different in different embodiments.

Capsular fixation strut: Retention strut; another term to refer to the novel protrusion from an intraocular lens; the said protrusion is capable of engaging a thin membrane (or lens capsule).

Gravity or external pressure: Pressure is used to force fluid or gas into the eye through the infusion cannula aspect to the surgical instrument. The pressure can be gravitational and controlled by raising or lowering the height of the fluid bottle. External pressure such as from compressed air or gas can also be placed into the infusion system design for pressurization. Tubing, gauges, controls, and monitors are used in some embodiments.

Blade attachment: The location where the cutting aspect of some embodiments of the instrument insert, join, or attach to the body of the instrument. Can be molded, welded, are otherwise joined mechanically.

Hand piece, instrument gripper: The instrument has aspects or features that enhance fingertip control with attachments, protrusions, or grooves on the external surface of the instrument.

Capsulotomy instrument can be pushed through one hollow bore: a device or tool that is capable of creating a small hole can be advanced through the lens insertion instrument in some embodiments.

Capsulotomy instrument can be a fiberoptic to transmit laser, a wire for thermo or electric cautery, a sharp instrument, or a vitrectomy type cutter.

Insertion instrument body: Made from metal, plastic, polymers, alloys, steel, ceramic, disposable or re-usable.

Length of instrument is variable: The instrument is of a length acceptable for ophthalmic surgery, without limitations. The length of the instrument is as short as 4 mm in some embodiments and as long as 20 mm in some embodiments. The instrument is of any length between 4 mm and 20 mm in some embodiments. In one embodiment the instrument is approximately 15 mm long. The insertion instrument, at the distal aspect is advanced through a corneal or scleral incision with a length of incision of between 1 mm and 5 mm. In one embodiment the distal aspect (distal most aspect is defined as between 1 mm from tip and 10 mm from tip) of the instrument can be advanced through an incision in an eye of a length between 1.8 mm and 3.2 mm. In some embodiments, the width of the distal aspect of the instrument is between 1 mm and 5 mm.

IOL in one lumen of instrument: One lumen or passageway of the instrument can accommodate the advancement of an intraocular lens through the distal opening.

Plunger types: There are multiple embodiments for the device that helps advance the IOL through the insertion instrument. In this invention those instruments can be defined broadly as plungers, advancement tools, lens pushers, lens advancement instruments, and can have picks, hooks, or jaws at the distal end in some embodiments. These aspects of the invention in some embodiments have: blunt ends, sharp ends, forceps, grabbers (a mechanical section that can grab, or hold and release an intraocular implant), hooks (small bends or loops), picks (small bent tips), and other shapes to enhance lens placement and manipulation.

New lens positioned in visual axis when primary IOL is off axis: A key opportunity inherent to this invention is the ability to improve the performance of artificial lens optics inside the eye by placing the new novel IOL with retention struts in or near the visual axis of an eye. The primary IOL is often off-axis based on positioning at the time of original surgery, or due to movement over time.

One reason this retention strut invention is novel is because individuals skilled in the art have not considered trans capsule fixation (through a newly made small capsulotomy hole) before. As an experienced retina surgeon, this inventor has realized that the lens capsule post cataract surgery has enough resiliency and strength to tolerate lens fixation in a penetrating manner.

Sunsetting IOL: A primary IOL that has decentered inferiorly in the anterior segment of the eye. This lens' optical axis is no longer in line with the optical axis of the eye.

Eye's visual axis: optical axis of the eye, visual axis of the eye.

Secondary IOL's visual axis: a line passing through the center of curvature of a lens or spherical mirror and parallel to the axis of symmetry. The lens has higher order corrections, corrections for astigmatism in some embodiments, and corrections for irregular astigmatism in some embodiments. In some embodiments, the optical axis of the novel IO with retention strut is considered a line passing through the center -point of the optic, or within 1 to 2 mm of the center point of the lens, perpendicular to the general orientation of the lens.

Molded in retention strut: The retention strut has a proximal end that is captured by the optic through molding, in some embodiments.

Piano: No spherical or astigmatic optical corrective power.

Capsular support ring: A polymer ring placed surgically in the recesses of the capsule to provide mechanical support for the capsule. The currently described novel IOL with retention strut is compatible with a Capsular support ring. An invention herein is the use of the novel IOL with retention strut in combination with a capsular support ring.

An invention described herein is the use of the novel IOL with retention struts in combination with an IOL or capsular tension or support ring that contains eyelets, or with engagement of the retention strut through eyelet holes on

Capsular bag: The capsule of the lens that surrounds the lens, or is a potential or real space for an IOL. There is an anterior leaflet and a posterior leaflet. These leaflets join at the recess of the capsule. An IOL m-the-gab has optics in the capsular bag. The optic is generally also in the bag. The capsule often has an anterior opening, and sometimes has a posterior opening. The capsule may have tears, an IOL present, and/or a capsular tension ring present.

Capsulorhexis: the process of tearing an opening in the anterior capsule, but can also refer to the opening itself.

Use for injuries to bag: The novel IOL with retention strut is compatible with an unstable or injured capsular bag, in some embodiments and/or situations.

Haptics: plastic side struts from an optic, to hold the lens in place within the capsular bag or sulcus, inside the eye; the key is that traditional haptics exert their stabilizing forces outward.

Plate haptics are haptics that are wide and flat, typically a plate haptic is nearly as wide as the optic. A plate haptics length allows for in-the-bag or sulcus fixation.

Loop haptics: Haptics with a curve or loop. The loop projects away from the optic and is a gentle "edge", with a dispersion of outward pressure in the bag or sulcus. The novel retention strut exerts pressure to the capsule in a completely different way. The novel IOL with retention struts can engage a thin membrane in space. The traditional or loop haptic IOL's are not designed for capture of a thin membrane in this manner, indeed they cannot be used to do so.

Multifocal: having more than one focal length, having several focusing areas that correct for both nearsightedness and farsightedness. Presbyopia: Presbyopia is a condition where, with age, the eye exhibits a progressively diminished ability to focus on near objects. After cataract surgery, in some patients, the essential nature of presbyopia persists. Many single power, and some premium IOL's do not provide acceptable near vision corrections

Presbyopic correction: refractive correction for presbyopia. Can be inside the eye with an IOL.

Accommodation: the process by which the vertebrate eye changes optical power to maintain a clear image or focus on an object as its distance varies. Used for near vision correction or to see at near. The natural lens can accommodate. Some IOL's accommodate. Some IOL's have moving parts or move relative to the cornea.

Pseudoaccommodation: Attainment of functional near vision in an emmetropic or distance-corrected eye without changing the refractive power of the eye. It may occur when the pupil is very small thus increasing the depth of field, in a presbyopic eye corrected with a progressive addition lens, in a pseudophakic eye corrected with a multifocal intraocular lens implant (IOL), or occasionally as a result of spherical aberration or astigmatism induced by corneal incisions made to insert an IOL.

Refractive error: A refractive error, or refraction error, is an error in the focusing of light by the eye and a frequent reason for reduced visual acuity. In normal population the dominant aberrations are the ordinary second-order spherocylindrical focus errors which are called refractive errors. Higher order aberrations are a relatively small component, comprising about 10% of the eye's total aberrations. High order aberrations increase with age and mirror symmetry exists between the right and the left eyes There are many sources of error. The novel IOL can address many of these sources in different embodiments.

Toricity/toric lens: A toric lens is a lens with different optical power and focal length in two orientations perpendicular to each other. One of the lens surfaces is shaped like a "cap" from a torus, while the other one usually is spherical. Toric lenses are primarily used in eyeglasses, contact lenses and intraocular lenses, to correct astigmatism. A lens that corrects for astigmatism is toric in some embodiments of this invention.

Torus: A torus is the spatial body resulting when a circle with radius r rotates around an axis lying within the same plane as the circle, at a distance R from the circle's centre. If R > r, a ring torus is produced. If R = r, a horn torus is produced, where the opening is contracted into a single point. R < r results in a spindle torus, where only two "dips" remain from the opening; these dips become less deep as R approaches 0. When R = 0, the torus degenerates into a sphere with radius r. Wavefront: a wavefront is the locus of points having the same phase: a line or curve in 2d, or a surface for a wave propagating in 3d. A wavefront is a surface over which an optical disturbance has a constant phase. Rays and wavefronts are two mutually complementary approaches to light propagation. Wavefronts are always normal (perpendicular) to the rays.

Aberrations of the eye: The eye, like any other optical system, suffers from a number of specific optical aberrations. The optical quality of the eye is limited by optical aberrations, diffraction and scatter. Correction of spherocylindrical refractive errors has been possible for nearly two centuries. It has only recently become possible to measure the aberrations of the eye and with the advent of refractive surgery it might be possible to correct certain types of irregular astigmatism. The appearance of visual complaints such as halos, glare and monocular diplopia after corneal refractive surgery has long been correlated with the induction of optical aberrations. Several mechanisms may explain the increase in the amount of higher-order aberrations with conventional excimer laser refractive procedures: a change in corneal shape toward oblateness or prolateness (after myopic and hyperopic ablations respectively), insufficient optical zone size and imperfect centration. These adverse effects are particularly noticeable when the pupil is large. The novel technology can correct optical aberrations of an eye.

Lower order aberrations: Includes Myopia (positive de focus), hyperopia (negative defocus), and regular astigmatism. Other lower-order aberrations are non- visually significant aberrations known as first order aberrations, such as prisms and zero-order aberrations (piston). Low order aberrations account for approximately 90% of the overall wave aberration in the eye Higher order aberrations: coma, spherical aberration, quadrafoil, trefoil, secondary coma, tip tilt correction, defocus, secondary astigmatism; can affect vision quality. There are numerous higher-order aberrations, of which spherical aberration, coma and trefoil are of key clinical interest. Spherical aberration is the cause of night myopia and is commonly increased after myopic LASIK and surface ablation. It results in halos around point images. Spherical aberration exacerbates myopia in low light (night myopia). In brighter conditions, the pupil constricts, blocking the more peripheral rays and minimizing the effect of spherical aberration. As the pupil enlarges, more peripheral rays enter the eye and the focus shifts anteriorly, making the patient slightly more myopic in low -light conditions. In general, the increase in overall wave aberration with pupil size has been reported to increase to approximately the second power of the pupil radius. This is because of the fact that most wave aberration is due to the 2nd order aberrations which have a square radius dependency. The effect of spherical aberration increases as the fourth power of the pupil diameter. Doubling pupil diameter increases spherical aberration 16 times. Thus, a small change in pupil size can cause a significant change in refraction. This possibility should be considered in patients who have fluctuating vision despite well-healed cornea following keratorefractive surgery. The current novel 10 L with retention struts and an opaque periphery, and a well centered position treats these pupil based abnormalities, in some embodiments. In some embodiments the combination of lens correction in the optic and smaller artificial pupil helps patients with these higher order aberrations. In some embodiments of this invention the novel IOL with retention struts has an optic with changes to intraocular lens that improve visual performance related to higher-order aberrations, or higher order corrections.

Coma is common in patients with decentered corneal grafts, keratoconus, and decentered laser ablations.

Trefoil produces less degradation in image quality compared with coma of similar root mean squared (RMS) magnitude.

Higher order corrections: corrects for higher order aberrations in an eye.

Correction: corrects for visual aberrations, or refractive errors of the eye.

Fish hook features: in some embodiments refers to barbs, protrusions, angled features, or blockers that help engage a retention strut through a thin membrane and prevent movement of the retention strut out of (or further through) the small hole.

Premium IOL: An IOL that is not covered by Medicare standard insurance payments for cataract surgery. A premium IOL is typically has a multifocal or accommodative component, or toric correction. A premium IOL generally is not a single power, non-accommodative, non tone lens. The novel IOL with retention strut can fit under a non- premium or premium definition depending on the embodiment and indications for use in a given patient.

Connection: For the purposes of the description of some embodiments of the insertion instrument, a connection is a conduit between one of the lumens or passageways and another. The connection is very small in some embodiments, enough for fluid or air. In some embodiments the connection is an opening in the walls of the passageways. It is inside the instrument in some embodiments. The connection is by external tubing or external open bore material in some embodiments. The connection is between another device or surgical system and one of the passageways of the insertion instrument in some embodiments.

Gradient: an increase or decrease in the magnitude of a property (e.g., expansion rate, polymeric composition, components, size, rate of change, stiffness, flexibility) observed in passing from one point or moment to another (one or more of the IOL, optic, retention strut, haptic, including protrusions, aspects, attachments, extensions, attributes, add-on, accessories, characteristics, features, elements of the novel IOL). Note: the terms attachments, add-ons, accessories, extensions, attributes, characteristics, features, elements, (singular or plural) are used to refer to or describe the wedges, barbs, progression blockers, bends, pins, rims, separators, and other modifications to the novel IOL, the retention struts, the haptics, the lens, the IOL with retention strut design. These features enhance, improve, or modify performance. Expandability and gradients and rates thereof, included.

Valve: a device for controlling the passage of fluid through a pipe or passageway or cannula, esp. an automatic or mechanical structured device or mechanism allowing movement in one direction only. A stopcock is used with the insertion instrument in some embodiments. A valve is found in any or the passageways or in connections to the passageways in some embodiments. The valve prevents fluid backflush from the eye externally in some embodiments, which helps maintain the anterior chamber in some embodiments. In some embodiments, a valve is used with the insertion instrument to improve performance . The valve prevents reflux or egress of fluid out of the system or instrument.

Infusion: Infuses fluids. Infuses fluid, liquid, gas, air, water, balanced salt solution, antibiotic solution, or other substance that would be helpful for eye surgery. Is supplied to the eye through an internal bore; infused through an internal bore. The infusion keeps the anterior chamber formed. In some embodiments the infusion has its own line. In some embodiments the infusion shares a passageway with another device or structure in the insertion instrument.

Barrel: Inside of the insertion instrument, a passageway inside the insertion instrument.

Energy: Energy is used to create the small capsulotomy: Laser, mechanical, electrical, thermal, radiofrequency, cautery, rotational, vibrational.

Customized lens: Modified for a particular individual.

Lens power: Diopteric, prismatic, or cylindrical power of a lens. Lens power can also include customized and higher order corrections.

Types of lenses used for an optic in the novel retention strut based lens: biconvex, piano convex, positive meniscus, negative meniscus, piano concave, biconcave, aspheric, special, customized, any combination thereof, including correction for presbyopia, myopia, hyperopia, astigmatism, higher-order aberrations, coma, prism, glare, diplopia.

Refractive index: a dimensionless number that describes how light, or any other radiation, propagates through that medium.

Leaflet: Either the posterior or anterior aspect of the lens capsule.

Examples: Surrogate novel lenses with retention struts were created by cutting lengths of between 5 mm and 12 mm of fiberoptic cable that was either 0.25 mm in diameter (fiber instrument sales, Inc.) and using optical glue (Norland Optical glue) to secure the section of fiberoptic cable across the center of commercially available intraocular lenses. In some examples either one or both haptics were broken off. A section of fiberoptic cable was placed on the optic of the lens. A drop of glue was placed. The optical glue was cured using heat in a traditional toaster oven. The surrogate lenses were examined and were acceptable from a size and exemplary proof-of- concept standpoint. Pseudophakic whole globe cadaver eyes were obtained from the tissue bank under approval based on the need to develop new therapies for eye disease. All local regulations were followed. Institutional review board approval was not required because of the cadaveric nature of the tissue and because there was no personally identifiable information associated with the cadaveric whole globes. The corneas were cloudy. The eyes were re-inflated by injecting water through the posterior sclera. The eyes were secured in Styrofoam with pins. A trephine was used to create an open sky surgical field. First the trephine was used to create a circular groove 8 mm in diameter. Then a corneal scissors was used to remove the corneal button. The wound size was enlarged to replicate entry through a more peripheral aspect of the cornea. The IOL was visualized in the capsular bag. Multiple different surgeries were performed. A small capsulotomy hole was made approximately 1 mm from the edge of the primary IOL optic by one of several methods for each surgery. First, a sharp needle was used. Second, a heated end of a paper clip was used. Third, a hand held ophthalmic cautery was used. The surrogate novel IOL was placed in the anterior chamber using forceps. In each case, the leading retention strut was e sily placed through the small capsulotomy so that it penetrated the capsule and engaged the capsule, and the lens was stabilized. In two experiments, there was a dual strut system, and the trailing retention strut was placed through the small capsulotomy that was made 180 degrees (on the other side of the optic) from the first small capsulotomy. The eye was manipulated and the second strut was placed. The secondary intraocular lens was held securely in place in the eye by the retention struts. In three experiments, the novel IOL was a one retention strut, one haptic device. The retention strut was easily placed through the small capsulotomy so that it penetrated the capsule and engaged the capsule. The trailing haptic was easily placed in the sulcus. The novel secondary lens was secure in the bag. The novelty of this invention is the use of the capsule in a penetrating fashion by an IOL with a retention strut to hold the IOL in place. The placement and security was performed in an ex vivo setting to show the idea was feasible and reduced to practice in a proof-of-concept manner.

Insertion Device: 1) A novel double barreled insertion device is printed on a. 3-D printer. It lias a leading edge blade, a bevel, lumen for infusion, and a lumen for a folded intraocular lens that can be advanced through the lumen.

2) A novel insertion instrument is crafted from multiple materials by an experienced jeweler. A 2.2 mm keratotomy blade is welded to a beveled single lumen lens insertion cannula, and a 30 g needle is welded to the two other pieces. The novel instrument with blade, bevel, and double lumen characteristics is made as a proof-of- concept as to manufacturing capability. The instrument is novel because no one has had an intraocular lens that can be placed as simply as the novel retention strut containing lens. The current device allows for an incision, or entry through an already made small incision with a small beveled instrument that maintains the anterior chamber and provides access to the anterior chamber for a secondary intraocular lens.

The novel IOL, retention struts, surgical tool, and related methods, techniques and devices may be used to provide a therapeutic alternative to patients with aphakia or pseudopha a. An apparatus to treat cataract is described in United States Patent 8,343,214 to Dr. David Kleinman and entitled "Apparatus For The Treatment of Cataract", the entire disclosure of which is incorporated herein by reference in it's entirety. An apparatus and method to treat presbyopia is described in United States Patent Application no. 61/819,636 entitled APPARATUS AND METHOD FOR THE TREATMENT OF PRESBYOPIA IN A PSEUDOPHAKIC EYE by Dr. David Kleinman, the entire disclosure of which is incorporated herein by reference in their entirety.

For further detailed specific elaboration as well as review, but in no way limiting, the novel technology and inventions of the current application include:

A novel lens including all of the following permutations and embodiments and descriptions, but without limitations:

A capsular retention strut that engages the capsule of the lens of an eye in a penetrating manner. A capsular retention strut that engages the capsule of the lens of an eye by using friction with force directed either posteriorly or anteriorly against either the anterior capsular leaflet, the posterior capsular leaflet, or both. A capsular retention strut that projects within 45 degrees of directly radially outward from the optic of an intraocular lens.

A lens with a projection of biocompatible material that protrudes primarily in a radial manner. An intraocular lens with at least one protrusion, here called a retention strut, from the optic of the intraocular lens that projects outwardly away from the optic; the diameter of the retention strut is between 0.01 mm and 3 mm; the retention strut has rigidity such that it can be directed by manipulation of the optic through a hole of 2 mm or less in a thin biological membrane; the retention strut has a length between 1 mm and 12 mm.

An intraocular lens with at least one protrusion, here called a retention strut, from the optic of the intraocular lens that projects radially outwardly from the optic; the diameter of the retention strut is between 0.01 mm and 3 mm; the retention strut has a length between 1 mm and 12 mm. An intraocular lens with at least one protrusion, here called a retention strut, from the optic of the intraocular lens that projects outwardly away from the optic and the distal aspect points away from the optic; the diameter of the retention strut is between 0.01 mm and 3 mm; the retention strut is joined at the optic in a method selected from a group that includes molding the retention strut to the optic at the time of intraocular lens molding and secondary placement of the retention strut through the optic following the manufacture of an intraocular lens optic with a small hole that is less than 3 mm in diameter and within 3 mm of the perimeter of the optic; the retention strut has rigidity such that it can be directed by manipulation of the optic; the retention strut has a length between 1 mm and 12 mm.

An intraocular lens with a protrusion, here called a retention strut, attached to the optic of the intraocular lens that projects outwardly away from the optic and does not have a distal loop; the diameter of the retention strut is between 0.01 mm and 3 mm; the retention strut has the rigidity such that it can be directed by manipulation of the optic; the retention strut projects away from the optic in a single anterior-posterior plane; the retention strut is a straight protrusion when viewed from the anterior perspective.

An intraocular lens comprising an optic with corrective power and a retention strut.

An intraocular lens with a protrusion attached to it that engages the lens capsule either by friction directed against the internal surface of the anterior or posterior capsule when the intraocular lens is in the bag, or in a penetrating manner when the intraocular lens is in the bag or the sulcus.

The retention strut has rigidity such that it can be directed by manipulation of the optic in a specific direction through a hole of 2 mm or less in a thin biological membrane; an intraocular lens comprising an optic with corrective power and a retention strut that has a leading wedge. An intraocular lens comprising an optic with corrective power and a retention strut that has and a lens progression blocking protrusion.

An intraocular lens comprising an optic and at least one capsular retention strut.

An intraocular lens comprising an optic and at least one capsular retention strut, where the retention strut is a protrusion from the optic designed to engage the lens capsule in a penetrating manner or by friction directed anteriorly or posteriorly against the distal end of the retention strut.

A retention strut for stabilizing an intraocular lens where the retention strut protrudes from the optic of the intraocular lens and projects away from the optic; the retention strut has a stiffness that allows for penetration of the capsule of the eye to secure the intraocular lens.

An intraocular lens with corrective power and a protrusion for stabilizing the intraocular lens inside the anterior segment of the eye; the protrusion penetrates the lens capsule and prevents movement of the intraocular lens in anterior, posterior, and toward the retention strut and away from it; the retention strut is one of more than one protrusions selected from a group including haptics and retention struts.

An intraocular lens with the flexibility to be folded for insertion through a small incision in the cornea into the anterior chamber of an eye where the intraocular lens has a protrusion that engages the capsule in a penetrating manner to secure the intraocular lens in position in the anterior segment of the eye.

An intraocular lens with the flexibility to be folded, and advanced through the lumen of an insertion instrument that passes through a small incision in the cornea, and placed into the anterior chamber of an eye where the lens unfolds and the intraocular lens has a protrusion that engages the capsule in a penetrating manner to secure the intraocular lens in position in the anterior segment of the eye.

An intraocular lens with a projection of biocompatible material that protrudes primarily in a radial manner.

An intraocular lens for implanting within a human eye, the eye having a natural capsular bag attached about its perimeter to the ciliary muscle of the eye and from which the natural lens matrix has been removed, the bag including an elastic posterior capsule urged anteriorly by vitreous pressure and an anterior capsule opening circumferentially surrounded by a capsular remnant which may be fused by fibrous tissue to the posterior capsule, said lens implant comprising:

an intraocular lens having anterior and posterior sides and including a central optic, and at least one generally rectilinear haptics (or retention strut) joined to and extending oppositely from the optic, and a distal wedge extending outwardly of the haptic (or retention strut), said haptic distal end portion is positionable through one or both leaflets of the capsular bag to fixate the haptic and retain the optic in the eye.

An intraocular lens suitable for use as an artificial lens implant in the human eye, comprising: a lens body having at least one member extendin from opposite sides of the periphery of said lens body, each of said position fixation members comprising a stem portion having first and second ends, and a peripheral portion extending to a position such that it may engage the tissue of the eye, each of members being located between said lens body and the peripheral portion of its position fixation member, said first end of each of said member being joined to said lens body, said second end of each of member being an outward projection, said first and second ends of each of said member project outwardly and posteriorly to said lens body, each of said second ends of member that when penetrating a thin membrane in an aqueous media at least one degree of freedom is limited.

Intraocular lens for insertion inside the eye of a mammal comprising: central lenticular means for refracting light entering the eye through the cornea before the light passes to the retina; and, at least one resilient or adequately stiff or expandable haptic for stabilizing and holding in place in the eye said central lenticular means, first ends of said resilient or adequately stiff or expandable haptic means fixedly attached to said central lenticular means and second ends of said resilient or adequately stiff or expandable haptic means wherein one of said second ends of said resilient or adequately stiff or expandable haptic means terminates in an outward direction such that the haptic is capable of penetrating through a small hole in a thin membrane and the intraocular lens is stabilized in a manner in at least one degree of movement.

An intraocular lens suitable for use as an artificial lens implant in the human eye, comprising: central lenticular means for refracting light; at least one protrusion that projects outward from the optic; said protrusion capable of being directed in the direction of the distal end of the protrusion by manipulation of the optic in the direction of the protrusion; said protrusion capable of being directed through a small hole in a thin membrane; said protrusion when passed through said small hole in said thin membrane limits freedom of movement of said lens in at least one degree of freedom.

An intraocular lens with a retention strut juxtaposed anteriorly to a lens already implanted in an eye.

Additionally described herein:

Retention strut made of polymers selected from a group including PMMA, acrylic, silicone, hydrogels, expandable hydrogels, other materials applicable and/or described herein.

Retention strut that is expandable

Retention strut that is made of a hydrophilic polymer that is in less than fully expandable state at conclusion of manufacturing such that it expands in the presence of aqueous fluid.

Retention strut that has a wedge leading edge and lens movement blocking protrusion Retention strut and optic with corrective power chosen from a group of optical, corrections including spherical, astigmatic, presbyopic, myopic, hyperopic, higher- order aberration, multifocal, and prismatic.

Retention strut that is part of the optic based on molding at manufacturing

Retention strut that is a separate piece from of the optic but is attached during the manufacturing process.

The retention strut is joined at the optic in a method selected from a group that includes molding the retention strut to the optic at the time of intraocular lens molding and secondary placement of the retention strut through the optic following the manufacture of an intraocular lens optic with a small hole that is less than 3 mm in diameter and within 3 mm of the perimeter of the optic

Retention strut projects straight; without a wide distal loop or without a distal curve

Retention strut of a different material than the optic.

Retention strut that is expands in a graded manner.

Gradient expansion of a retention strut

Method for making a retention strut with a gradient expansion; manufacturing approaches such that the polymer has a different expansile property as one moves from distal to proximal (toward the optic) on the strut. A variety of polymers exist where one can spatially control the expansion. One class of intraocular lens materials are hydrogels, which consist of a crosslinked polymer network which is swollen in water. In one embodiment, hydrophilic (polar) groups in a hydrogel can be generated from hydrophobic groups with the local application of a stimulus (i.e. light, heat). The polymer can be irradiated locally with light or heat using a laser and restoring over certain regions, or by the use of covering certain regions with a mask as is done during lithographic processes. When the hydrophobic groups are converted to hydrophilic groups, the hydrogel will take up more water in the exposed regions and in turn cause expansion where the stimulus was applied. As an example, a thermal labile ester can be used in the hydrogel formulation such as t-butylmethacrylate. By locally heating the polymer hydrogel with a laser, thermolysis of the ester is induced thereby creating a carboxylate, causing the crosslinked network to swell. T-butylmethacrylate is not meant to be limiting and there are a number of thermally labile esters known to those of skill in the art.

The conversion of hydrophobic groups to hydrophilic groups is also being achieved using light of various wavelengths and photolabile compounds. In one embodiment, a nitrobenzylic ester is deprotected to form the carboxylic acid with the application of light. There are a number of other compounds which can be deprotected with the application of light to generate an acid group and several examples of such compounds are disclosed in US 7301049 (Photolabile esters and their uses). Upon photolysis of these groups with a laser or other local application of light, the acid group takes up more w^rater into the hydrogel causing local swelling.

The generation of a carboxylic acid group within a hydrogel is also not intended to be limiting. Other polar groups can also be created to allow the polymer to become more hydrophilic. Several examples would include protected amines and protected alcohols that form -NH2 groups or -OH groups when exposed to a stimulus.

Another mechanism to induce local swelling in a crosslinked polymer is to induce migration of monomers to an area that is being irradiated. In one such embodiment, a silicone elastomer network infused with polymerizable silicone can be used to cause gradient volume changes. This system is analogous to the Calhoun Vision Light Adjustable Lens (LAL®), where local shape change is induced by exposure to UV light. In this case a polymerizable silicone can migrate to the point of irradiation and then be fixated by photopolymerization. Silicone elastomers are another category of intraocular lens material and it is important to note that these materials do not contain water and that the local swelling is caused by migration of material. The migration of monomers to a reactive site would also work for a variety of hydrophobic acrylic IOL's where polymerizable macromonomers can be embedded in a crosslinked polymeric network. Such a technique for causing swelling, shape changes or localized swelling are embodiments described herein.

These inventions are also described:

Retention strut with proximal protrusion that allows for attachment to the optic.

Retention strut placed into the eyelets of a primary intraocular lens.

Retention strut interacts with eyelets of a capsular tension ring.

Retention strut that expands on exposure to aqueous media.

Retention strut that expands on exposure to light or heat.

Retention strut that has any components described in the specification and or figures. Novel insertion instruments are described:

An instrument that contains a lumen for the placement of a folded intraocular lens into the eye; the instrument has infusion fluid running through it with an opening of the infusion lumen close enough to the distal aspect of the instrument so that it can be accommodated in a space with the dimensions of the anterior chamber of a human eye.

An instrument that contains a lumen of internal diameter capable of accommodating a folded intraocular lens; the instrument has a sharp leading edge that is capable of making a surgical i cision in the eye wall; and the leading sharp edge is close enough to the lumen's opening at the distal tip of the instrument such that the entire opening and the distal tip of the instrument can be contained in a space witli the dimensions of the anterior chamber of a human eye.

An intraocular lens insertion instrument that has a sharp distal tip for the creation of an incision, a bevel allowing for progressively rounder distal aspect of the instrument to enter the eye as it is advanced, and an infusion lumen; the infusion and intraocular lens lumens both exit the instrument with 10 mm of the distal tip of the instrument.

Embodiments include, without limitations.

The leading edge of the instrument is beveled.

The leading edge of the instrument is a blade.

The instrument is a dual lumen device.

The instrument is a triple lumen device.

The instrument has two openings inside the eye.

The instrument has three openings inside the eye.

The instrument is used in combination with a lens advancement tool.

The lens advancement tool is rigid.

The lens advancement tool is flexible.

The lens advancement tool has a protrusion selected from the group including bends, picks, jaws, and forceps.

Methods for manufacturing a retention-strut based intraocular lens such that varying degrees of polymer ratios are utilized for different aspects of the retention strut are described.

Methods also exist for making an intraocular lens composed of different materials at different zones or regions for the device. In one embodiment, a polymeric button can be made that has concentric zones of slightly different formulation mixtures, such that a lens body and its retention strut (and or haptics) can be lathe cut from the button. In this example, the concentration of a hydrophilic monomer increases as you go from the center to the periphery of the button, so when the intraocular lens is hydrated, there is increased swelling as you move distally from the lens body. In this example the retention strut would swell more as you move away from the lens body, however it should be noted that this can also be reversed.

In certain embodiments, the chemistry can be tuned to control the swelling kinetics. This allows the delivery and placement of the lens before the retention strut swells and can fixate the lens body. In essence, with the correct formulation one can preprogram the degree of swelling and the work time for placement of the lens.

In addition, fabrication techniques exist that allow for the retention strut to be made separate from the lens body and then glued into the lens body post fabrication of the optic. In such embodiments the retention strut (and or haptics) can be made out of a hydrogel material and the lens body can be made of a similar or different material. For example, in one embodiment the lens body consists of a silicone elastomer or hydrophobic acrylic. It should also be noted that when the lens strut is made separately from the lens body, it can also be engineered to swell differently along its axial length by the previously mentioned techniques of localized exposure to a stimulus. Such differential swelling has the benefit of altering the affect at the joint or attachment of retention strut and lens.

In addition to lathe cutting the retention strut (and or haptics), or making them separate from the lens body, they are cast molded with the lens in some embodiments or approaches to manufacturing. For example, someone skilled in the art of intraocular lens manufacture can conceive several methods for manufacturing prototype and production lenses with retention strut of the current invention. Molded processes with secondary manipulation or combined processes are applicable. The lenses will be sterilized and packaged for shipping. The lenses will be stable in the eye indefinitely based on materials, design, and manufacturing. All of these fabrication and manufacturing techniques are used to make intraocular lenses. The spirit of this invention, in part, is to use materials that are programmed to swell differentially with respect to location and not specific to certain manufacturing techniques. The spirit of this invention, in part, is to attach a retention strut to an artificial lens for an eye and not specific to certain manufacturing techniques.

Also described:

Methods of preparation of the device outside the eye, including attaching infusion to a lens insertion instrument, and placing an intraocular lens in an instrument with a blade, placing the intraocular lens inside an instrument with an infusion.

Initiating a swelling process in a lens for insertion in the eye (novel lens with retention strut as described herein, for example as one embodiment) before it is placed in the eye.

A tool deployable through a lens insertion instrument that has a tip energized with electricity such that the tip reaches a temperature of sufficient to cauterize the lens capsule.

The infusion can be turned on and off as needed during the surgical procedure. The infusion is pressured so that it maintains the eye pressure. The pressure is set by the height of the bottle or by a compressed air system. One aspect of this invention is the placement of a custom secondary IOL in front of a primary IOL. The invention includes the placement of single power, premium (multifocal or accommodating), presbyopic corrective, and toric secondary IOL's. The novel IOL of the present invention may be aspheric. These lenses can typically correct lower order aberrations such as negative defocus (myopia) positive defocus (hyperopia) and regular astigmatism, and presbyopia. When referring to custom the intent also included lenses manufactured specifically for a patients residual higher order aberrations. Wave front technology, corneal and/or other aberration detecting methods may be used to identify, detect, measure, or evaluate higher order aberrations. Higher order aberrations include but are not limited to spherical aberration, coma, and trefoil. Measuring wave front and refraction in an eye can be used to generate a custom secondary IOL for the current invention. Shack-Hartman, Tschering systems, ray tracings, Skiascopy, and other types of aberrometers are some of the methods that may be used for detecting the pseudophakic eye's aberrations. The method for the detection of aberrations is not limited to these tests for determining the custom secondary IOL of the present invention. RMS, Zernike polynomials, and other methods may be used to quantify aberrations when planning for a custom secondary IOL of the present invention. The information gathered about aberrations of the subjects eye can then be used to custom manufacture lenses that correct for these aberrations using lathe cutting, laser treatment following initial manufacture, molding and casting processes, and three dimensional printing to manufacture the custom secondary IOL. Another aspect of the invention is the use of three dimensional printing to create, test, and manufacture custom IOL's of the present discussion herein (IOL with a retention strut. The secondary lens of the present invention is a gradient index lens (GRIN) in some embodiments.

It is, therefore, apparent that there has been provided, in accordance with the various objects of the present invention, devices for the treatment of refractive error in an aphakic or pseudophakic eye. While the various objects of this invention have been described in conjunction with preferred embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the present invention and the various embodiments described and envisioned by this specification, claims and attached drawings.

Claims

What is claimed is:

1. An intraocular lens for implanting within an eye of a patient, the intraocular lens comprising: a lens comprising a central optic, an anterior side and a posterior side;

a retention strut having a proximal end that is joined to the lens and a distal end that is not joined to the lens;

the retention strut extending away from the lens and capable of engaging and penetrating at least one capsular leaflet of the eye.

2. The intraocular lens of claim 1, further comprising a progression blocker located between the proximal end of the retention strut and the distal end of the retention strut.

3. The intraocular lens of claim 1, wherein the retention strut contains a bend to allow for redirection of the distal end of the retention strut.

4. The intraocular lens of claim 1 , further comprising a wedge attached to the distal end of the retention strut.

5. The intraocular lens of claim 1, wherein the retention strut is made from a hydrophilic material.

6. The intraocular lens of claim 1, further comprising a haptic.

7. The intraocular lens of claim 4, wherein the retention strut has a bend projecting the wedge anterior to the lens.

8. The intraocular lens of claim 1, further comprising a protrusion separator extending perpendicularly from the lens.

9. The intraocular lens of claim 6, wherein the haptic is selected from the group consisting of a traditional open loop haptic, a closed loop haptic, a double closed loop haptic, a plate haptic, and an S-curve haptic.

10. The intraocular lens of claim 1 , further comprising a lens movement blocker extending from the optic.

11. The intraocular lens of claim 1 , further comprising a second retention strut.

12. The intraocular lens of claim 1 1, further comprising a wedge attached to the distal end of the second retention strut.

13. The intraocular lens of claim 11 , wherein the second retention strut contains a bend to allow for redirection of the distal end of the second retention strut.

14. The intraocular lens of claim 13, wherein the bend projects the retention strut anterior to the lens.

15. The intraocular lens of claim 11 , wherein the second retention strut is made from a hydrophilic material.

16. The intraocular lens of claim 1, wherein the lens is flexible and capable of insertion through a small incision in the cornea of the eye into the anterior chamber of the eye.

17. The intraocular lens of claim 1, wherein the lens of the central optic is selected from the group consisting of single power, multifocal, presbyopic correcting, toric, accommodating, pin hole, ultraviolet blocking, blue light filtering, spheric, aspheric, and apodized diffr ctive.

18. An intraocular lens for implanting within an eye of a patient, the intraocular lens comprising:

a lens comprising a central optic, an anterior side and a posterior side;

the retention strut extending at least in part anterior to the lens and capable of engaging with the anterior capsule in a penetrating manner.

19. The intraocular lens system of claim 18, wherein a wedge is attached to the distal end of the retention strut.

20. An intraocular lens comprising:

an intraocular lens for implanting within an eye of a patient, the intraocular lens comprising: a lens comprising a central optic, an anterior side and a posterior side;

the retention strut extending away from the lens and capable of engaging with at least one capsular leaflet of the eye; and

a wedge attached to the distal end of the retention strut.