WO1992014421A1 - Verre ou lentille oculaire attenuant l'effet de 'halo' en chirurgie d'implantation par incision legere - Google Patents

Verre ou lentille oculaire attenuant l'effet de 'halo' en chirurgie d'implantation par incision legere Download PDF

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Publication number
WO1992014421A1
WO1992014421A1 PCT/US1992/001340 US9201340W WO9214421A1 WO 1992014421 A1 WO1992014421 A1 WO 1992014421A1 US 9201340 W US9201340 W US 9201340W WO 9214421 A1 WO9214421 A1 WO 9214421A1
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WO
WIPO (PCT)
Prior art keywords
lens
layer
transmissivity
optic
range
Prior art date
Application number
PCT/US1992/001340
Other languages
English (en)
Inventor
Dennis T. Grendahl
Fritz D. Harnsberger
David R. Foehl
Original Assignee
Grendahl Dennis T
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Grendahl Dennis T filed Critical Grendahl Dennis T
Publication of WO1992014421A1 publication Critical patent/WO1992014421A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • A61F2/1613Intraocular lenses having special lens configurations, e.g. multipart lenses; having particular optical properties, e.g. pseudo-accommodative lenses, lenses having aberration corrections, diffractive lenses, lenses for variably absorbing electromagnetic radiation, lenses having variable focus

Definitions

  • This invention relates to ophthalmic prosthetic devices or lenses which significantly reduce glare or halo experienced by a patient subsequent to lens implant surgery. More particularly, the present invention relates to intraocular lenses, especially smaller-sized, posterior chamber intraocular lenses, which are implanted in the eye through minimally sized surgical incisions. This technique is sometimes referred to as small incision surgery. Yet more particularly, this invention relates to intraocular lenses which reduce glare associated with incident light by means of a thin coating or layer of low light transmissivity material located substantially on the edge or perimeter of the lens body.
  • the lenses of human and animal eyes are subject to damage by physical or other external trauma whether accidental or otherwise and by the formation of cataracts. It has been common practice for many years to remove surgically such damaged lenses. An eye with the lens removed is said to be in the aphakic condition.
  • the aphakic eye does not have the same ability to focus light with the result that the retina receives only a blurred image.
  • Contact lenses, spectacles or a combination of the two have been used in the past with varying degrees of success to focus the light rays on the retina to restore vision.
  • the use of contact lenses and eye glasses to overcome aphakia is subject to the fundamental drawback that such devices are located external to the eye. The use of such external devices results in a shift of the optical center from its normal position within the eye to outside the eye. This can result in distortions and/or changes in the size of the image.
  • Cataracts are the most common disorder of the eye and are the second leading cause of blindness in the
  • a cataract is a biochemical change in the structure of the lens of the eye which causes transformation of the normally transparent lens to a cloudy or opaque state.
  • the function of the lens is to focus light rays to form an image on the retina.
  • Cataracts interfere with the focusing of the light rays causing the image to become * blurred, and eventually, leading to blindness if unattended.
  • the opacity caused by cataracts are often not distributed uniformly so that the lens has both opaque and transparent zones or regions. Thus, the resulting loss of vision depends upon the size, the location, and the densities of the lens opacities.
  • a cataract is treated surgically under local anesthesia, in which the cataractous lens is removed.
  • This procedure is one of the most common operations performed by ophthalmic surgeons. During the operation, the surgeon views the operation site through a high powered microscope to facilitate the procedure. The eye normally is kept moist with physiological saline throughout the procedure.
  • Standard procedure for removing the damaged lens involved first dilating the pupil and then making a half circle incision at the junction of the sclera and the clear cornea i.e, in the conjunctive and limbus. The upper half of the cornea was retracted, as was the iris, to provide access to the lens. The lens was then removed by one of several techniques. For example, phaco- emulsification involves the ultrasonic fragmentation of the lens into small particles. Once phaco-emulsification has been accomplished, the particles are removed by aspiration leaving a clean lens capsule free from cataractous material. The instrumentation used in phaco-emulsification permits the length of the surgical incision to be as little as 3mm or less. Provided the implanted lens is of a similar size, less traumatic lens implantation surgery through smaller surgical incisions is possible.
  • This circular halo or glare is potentially disturbing to the patient, and generally is to be minimized or eliminated.
  • U.S. Patent 3,454,332 to R. Siegel discloses a corneal plastic contact lens with a multiplicity of colored peripheral zones. The colored zones of Siegel radiate from a central colorless zone.
  • Kelman disclose intraocular lenses which can be inserted through incisions which are less than 5mm. in length.
  • the Kelman patents disclose a masking means which overlies a peripheral marginal portion of the lens body or optic to prevent glare.
  • the masking means is deformable between an expanded condition and a retracted condition.
  • U.S. Patent 4,556,998 to Steven B. Siepser discloses an intraocular lens comprising a hydrophilic material which is capable of expanding in dimension by absorption of natural eye fluid.
  • the Siepser lens when implanted, has a small diameter and, after absorbing eye fluid, expands to a larger diameter.
  • the present invention is a glare-reducing or halo-reducing ophthalmic lens or intraocular lens capable of being implanted with small incision implant surgery, the lens comprising a lens body or optic having a transmissivity, for visible light, in the range of about 60% to about 100%, preferably, about
  • the optic has, on its perimeter, a layer or coating of a material having a transmissivity to visible light in the range of about 0% to 40%, preferably, about 5% to 25%.
  • the coating of this invention has a minimal radial or lateral thickness or annular width which significantly reduces glare due to light impinging upon and being transmitted through the lens body. The perception of the lens implant patient is the best indicator of whether glare reduction has been significant.
  • the lens body or optic is substantially colorless and the layer or coating is an intense, substantially opaque or non-visible-light-transmissive blue.
  • the optic of the present invention further comprises positioning loops or haptics.
  • the haptics of this invention may, in the user's preference, comprise a low transmissivity material (e.g., a colored material), or a high transmissivity material, (e.g., a colorless material).
  • the optic or lens body has a sufficiently small diameter so as to permit it to be inserted or implanted using small incision implant surgical techniques. Generally this means that lenses of this invention can be implanted through an incision in the eye of 6mm or less, in length. Preferably, lenses of this invention have a diameter which permits them to be implanted through surgical incision of less than 5.5mm in length, preferably lens than 5.0mm.
  • Visible light herein means light having a wavelength in the range of about 400nm to 800nm.
  • coating or “layer” of a low transmissivity material are used extensively in the present application. These terms are intended to be used so as to distinguish from a substantially thicker ring, zone, or region of a colored material.
  • a coating or layer may have a radial thickness or width in the range of from about 2 to 3 dye molecule diameters up to about 250 microns. The radial thickness of the coating is preferably less than about 10 microns and most preferably less than about 1 micron.
  • the terms “coating” or “layer” refer to materials which lie on the surface of the lens optic that is, which are not part of the optic at all, or which permeate into the bulk of the optic only to the extent necessary to provide adherence thereto.
  • a suitably biocompatible and opaque dye for use in this invention may permeate a short distance into the lens body.
  • the minimum thickness and annular width of the coating is that which will restrict transmission of incident light from the lens perimeter through the coating to the body of the lens optic and vice versa. By this expedient patient or user glare or "halo" is reduced or eliminated.
  • this invention is particularly applicable to lenses of a diameter which makes them suitable for small incision surgery.
  • Fig. 1 illustrates a top view of an intraocular lens according to the present invention
  • Fig. 2 illustrates a sectional view of the intraocular lens depicted in Fig. 1 taken along line 2-2;
  • Fig. 3 is a top view of an embodiment of the present invention wherein the lens optic is polygonal. Detailed Description of the Invention
  • Fig. 1 illustrates an intraocular lens 10 of the present invention including a lens body or optic 12 and two positioning loops or haptics 14 and 16.
  • the lens optic 12 includes an essentially clear or colorless lens body 20 having on its edge or perimeter a colored coating or layer 22.
  • the entire assembly is made of any biocompatible material having suitable optical characteristics. While described with respect to intraocular lenses, other ophthalmic lenses, such as corneal inlays, also may use this invention.
  • PMMA polymethymethacrylate
  • other ophthalmic lens materials such as polysulfone, polythersulfone or polycarbonate are utilized to manufacture lens bodies.
  • the colored layer 22 is sufficiently darker in color to substantially reduce the intensity of visible light transmitted from lens body 20 to or through colored layer
  • the annular width of the coating 22 is selected to provide adequate space for the attachment of the loops 14 and 16. Haptics may be added by known processes such as staking, adhesive bonding, or ultrasonic bonding.
  • the annular width of lens 10 is also sufficient to provide adequate reduction in the intensity of the light transmitted from the periphery to the central portion of the lens 10 (and vice versa) .
  • Loops 14 and 16 optionally may be made of colored material. This further reduces the intensity of the light transmitted to the clear central portion 20.
  • the loops 14, 16 can be made of a colorless material similar to that used in the lens body 20. The same discussion applies to intracorneal lens edge effects.
  • Positioning holes or locating holes optionally may be provided in the optic body 12.
  • the lens body or optic 12 of this invention has a transmissivity to visible light in the range' of about 60% to about 100%, preferably about 80% to 95%. Transmissivity is measured using known methods. In a preferred practice, the lens body is also substantially clear, or more precisely, colorless. It is contemplated that lens body 12 will have the requisite transmissivity and yet not be colorless. For example, an ultraviolet absorptive material may be included in the lens body composition. Such a material may impart a color, e.g., yellow, to the lens body and slightly to substantially reduce its visible light transmissivity.
  • Fig. 2 shows a sectional view of the lens of Fig. 1 taken along the line 2-2.
  • the colored portion, layer, or coat 22 extends annularly from the rear surface of the lens 24 to the front surface of the lens 26, that is, from rear edge 28 to front edge 30. While it is not necessary that the entire edge of the lens body be coated, the edge must be sufficiently coated to reduce the halo effect discussed above.
  • Fig. 3 shows an optional polygonal shape for lens body or optic 12.
  • Optic 12 of Fig. 3 is octagonal. Many other lens shapes are possible within the contemplation of the present invention.
  • coating or layer 22 is located substantially along the entire outer perimeter or edge of lens body 20.
  • lenses of this invention are implanted using small incision surgical techniques.
  • Small incision implant surgery as the term is used herein generally means implantation of an artificial ophthalmic prosthetic device, such as an intraocular lens, through a surgical incision which is less than about 5.5mm in length and which is preferably less than about 5.0mm in length.
  • a lens capable of being implanted via small incision implanted surgery can have a diameter of about 0.5mm greater than the length of the incision through which it is to be inserted.
  • a lens implantation using small incision techniques can have a diameter of about 6.5mm or less and preferably less than about 6.0mm.
  • a lens of this invention will have a diameter of less than about 5.0mm. This is to be contrasted with the diameter of prior art lenses used in large incision implant surgery where incisions of 7.0mm and up to 12.0mm or longer (the lenses being proportionately sized) were necessary.
  • lens body or optic 12 may be completely masked with the exception of its edges. The masked optic may then be dipped into a suitable solution of a low transmissivity, generally colored, material. This technique would be used when it is desired to have a very thin layer or coating of colored material.
  • a solution of methylene chloride, a dye, such as green dye number 3, and the polymeric material of which lens body 12 is comprised may be prepared. It is desirable to use some proportion of the lens body polymer in the solution to restrict possible erosion of the lens body itself when it is dipped in the colored solvent solution.
  • the masked lens is then dipped in the above solution and the solvent permitted to evaporate.
  • This preparative technique provides a very thin layer of colored material with minimal penetration of the colored material into the lens body.
  • colored material may penetrate radially into the lens body as little as the diameter of two or three dye molecules. Removal of the mask subsequent to evaporation of the solvent produces an intraocular lens of the present invention.
  • a mixture of a powdered pigment, for example, copper blue, a solvent, such as methylene chloride, and a mixture of methylmethacrylate monomer and polymethymethacrylate is prepared.
  • a powdered pigment for example, copper blue
  • a solvent such as methylene chloride
  • a mixture of methylmethacrylate monomer and polymethymethacrylate is prepared.
  • the above mixture is precision painted or rolled onto the edge of the optic. This rolling or painting step may be accomplished using commercially available precision application equipment.
  • the solvent may then be evaporated either at room temperature or elevated temperature if processing time is to be shortened.
  • a continuous, dense colored coating is applied to the edge of the optic body.
  • a thin, e.g., about 0.01mm to about 0.1mm, sheet of highly pigmented polymethymethacrylate (PMMA) sheet is wrapped around a central optic core of substantially colorless polymethymethacrylatehavingtherequiredtransmissivity.
  • PMMA polymethymethacrylate
  • the sheet of colored PMMA then is securely anchored or bonded to a tube or rod of lens core material, e.g., by heating.
  • the lens body then is machined or sliced from this composite structure.
  • Optional haptics may then be added by conventional techniques discussed above.
  • this invention is particularly applicable to intraocular lenses.
  • Anterior chamber and posterior chamber lenses are within its scope.
  • the glare or halo reduction characteristics of other ophthalmic lens prosthe ⁇ es, e.g., intracorneal inlays, or corneal lenses, may be enhanced by application of this invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Verre ou autre dispositif oculaire (10) de prothèse, notamment lentille intra-oculaire pour implantation par incision légère ayant pour effet de réduire considérablement le phénomène d'éblouissement dit 'halo'. Le dispositif se compose d'une lentille ou optique (20) constituée d'un matériau présentant une première caractéristique de transmissibilité, cet organe comportant en sa zone périphérique une couche (22) d'une matière ayant une deuxième caractéristique, plus faible, de transmissibilité. Cette couche (22) présente une épaisseur radiale minimale de manière à atténuer dans des proportions appréciables l'effet d'éblouissement dit 'halo' dû à la lumière incidente. Dans une configuration préférentielle, la transmissibilité de l'élément optique (20) par rapport à la lumière visible se situe dans la fourchette des 60 à 100 %, de préférence entre 80 et 95 %. La transmissibilité de la couche (22) par rapport à la lumière visible se situe entre 0 entre 40 %, de préférence entre environ 5 et 25 %. Dans une autre configuration également privilégiée, l'élément optique (20) est pratiquement incolore et la couche (22) est d'un bleu intense.
PCT/US1992/001340 1991-02-21 1992-02-20 Verre ou lentille oculaire attenuant l'effet de 'halo' en chirurgie d'implantation par incision legere WO1992014421A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US65957391A 1991-02-21 1991-02-21
US659,573 1991-02-21
US07/838,362 1992-02-19

Publications (1)

Publication Number Publication Date
WO1992014421A1 true WO1992014421A1 (fr) 1992-09-03

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PCT/US1992/001340 WO1992014421A1 (fr) 1991-02-21 1992-02-20 Verre ou lentille oculaire attenuant l'effet de 'halo' en chirurgie d'implantation par incision legere

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0599457A1 (fr) * 1992-09-28 1994-06-01 Iolab Corporation Lentille ophtalmique avec réduction de l'éblouissement marginal
US5755786A (en) * 1992-09-28 1998-05-26 Iolab Corporation Ophthalmic lens with reduced edge glare
WO2004030580A1 (fr) * 2002-09-25 2004-04-15 Bausch & Lomb Incorporated Lentille intra-oculaire
DE102005053078A1 (de) * 2005-11-04 2007-05-10 Dr. Schmidt Intraocularlinsen Gmbh Intraokularlinse
US9949822B2 (en) 1998-05-29 2018-04-24 Johnson & Johnson Surgical Vision, Inc. Intraocular lens for inhibiting cell growth and reducing glare

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4605409A (en) * 1984-05-21 1986-08-12 Kelman Charles D Intraocular lens with miniature optic having expandable and contractible glare-reducing means
US4774036A (en) * 1985-08-01 1988-09-27 Dennis T. Grendahl Method of making an intraocular lens

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4605409A (en) * 1984-05-21 1986-08-12 Kelman Charles D Intraocular lens with miniature optic having expandable and contractible glare-reducing means
US4774036A (en) * 1985-08-01 1988-09-27 Dennis T. Grendahl Method of making an intraocular lens

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0599457A1 (fr) * 1992-09-28 1994-06-01 Iolab Corporation Lentille ophtalmique avec réduction de l'éblouissement marginal
US5693093A (en) * 1992-09-28 1997-12-02 Iolab Corporation Ophthalmic lens with reduced edge glare
US5755786A (en) * 1992-09-28 1998-05-26 Iolab Corporation Ophthalmic lens with reduced edge glare
US6045577A (en) * 1992-09-28 2000-04-04 Iolab Corporation Ophthalmic lens with reduced edge glare
US9949822B2 (en) 1998-05-29 2018-04-24 Johnson & Johnson Surgical Vision, Inc. Intraocular lens for inhibiting cell growth and reducing glare
WO2004030580A1 (fr) * 2002-09-25 2004-04-15 Bausch & Lomb Incorporated Lentille intra-oculaire
DE102005053078A1 (de) * 2005-11-04 2007-05-10 Dr. Schmidt Intraocularlinsen Gmbh Intraokularlinse

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