EP4294325A1 - Lentille intraoculaire composite réglable par la lumière à structure diffractive - Google Patents

Lentille intraoculaire composite réglable par la lumière à structure diffractive

Info

Publication number
EP4294325A1
EP4294325A1 EP22756734.4A EP22756734A EP4294325A1 EP 4294325 A1 EP4294325 A1 EP 4294325A1 EP 22756734 A EP22756734 A EP 22756734A EP 4294325 A1 EP4294325 A1 EP 4294325A1
Authority
EP
European Patent Office
Prior art keywords
diffractive
light adjustable
intraocular lens
lens
iol
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP22756734.4A
Other languages
German (de)
English (en)
Inventor
Ilya Goldshleger
John Kondis
Ronald M. Kurtz
Ritu Shrestha
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
RxSight Inc
Original Assignee
RxSight Inc
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
Priority claimed from US17/180,790 external-priority patent/US20210251744A1/en
Application filed by RxSight Inc filed Critical RxSight Inc
Publication of EP4294325A1 publication Critical patent/EP4294325A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1613—Intraocular 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
    • A61F2/1654—Diffractive lenses
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B1/00—Optical elements characterised by the material of which they are made; Optical coatings for optical elements
    • G02B1/04—Optical elements characterised by the material of which they are made; Optical coatings for optical elements made of organic materials, e.g. plastics
    • G02B1/041—Lenses
    • G02B1/043—Contact lenses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/1681—Intraocular lenses having supporting structure for lens, e.g. haptics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/16965—Lens includes ultraviolet absorber
    • A61F2002/1699—Additional features not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0053—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in optical properties
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/14—Photorefractive lens material
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/16—Laminated or compound lenses
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C2202/00—Generic optical aspects applicable to one or more of the subgroups of G02C7/00
    • G02C2202/20—Diffractive and Fresnel lenses or lens portions
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G—PHYSICS
    • G02—OPTICS
    • G02C—SPECTACLES; SUNGLASSES OR GOGGLES INSOFAR AS THEY HAVE THE SAME FEATURES AS SPECTACLES; CONTACT LENSES
    • G02C7/00—Optical parts
    • G02C7/02—Lenses; Lens systems ; Methods of designing lenses
    • G02C7/04—Contact lenses for the eyes

Definitions

  • FIGS. 7A-C illustrate a formation of a counter-rotating toric pattern in an implanted rotated toric CLA IOL.
  • FIGS.8A-C illustrate the formation of an analogous counter-rotating cylinder using a vector formulation.
  • FIG.9 illustrates a method of adjusting a composite light adjustable IOL.
  • FIGS.10A-B illustrate chromatic aberration-reducing CLA IOLs.
  • FIG.11 illustrates the chromatic shift of a CLA IOL, in comparison to a regular IOL.
  • FIGS.12A-B illustrate PCO-suppressing aspects of an achromatic embodiment of the composite light adjustable IOL.
  • FIG.13 illustrates embodiment of the composite light adjustable IOL with an adhesion promoter.
  • FIGS. 14A-C illustrate cross-sectional views of embodiments of the composite light adjustable IOL.
  • FIGS. 15A-B illustrate embodiments of the composite light adjustable IOL with different incorporations of the adhesion promoter.
  • FIGS. 16A-B illustrate embodiments of the composite light adjustable IOL with different incorporations of the adhesion promoter.
  • FIGS. 17A-C illustrate embodiments of the composite light adjustable IOL with different incorporations of the adhesion promoter.
  • FIGS. 18A-B illustrate embodiments of the composite light adjustable IOL with differently positioned UV absorbing layers.
  • FIG.26 illustrates a composite light adjustable IOL with an adhesion promoter.
  • FIG.27 illustrates a composite light adjustable IOL with an attachment structure.
  • FIG.28 illustrates a composite light adjustable IOL with a diffractive light adjustable lens.
  • toric IOLs an unintended rotation of the toric IOL axis by only 10 degrees after implantation can cause about 30% loss of efficiency.
  • a nominal 3D cylinder of a toric IOL can be reduced to an effective 2D cylinder if the cylinder axis ends up rotated by only 10 degrees during or after implantation.
  • Light adjustable IOLs can be implanted without any preformed toric cylinder. After the implantation, when the IOL settled and stopped its unintended rotation, the surgeon can apply an illumination to form a cylinder in the settled IOL, with its axis oriented exactly in the planned or targeted direction.
  • FIG. 1 illustrates a top view of a composite light adjustable intraocular lens 100 that includes an intraocular lens (IOL) 110, a light adjustable lens (LAL) 120, attached to the intraocular lens 110; and haptics 114-1 and 114-2, cumulatively also referred to as haptics 114.
  • the haptics 114 can include various number of haptic arms. Embodiments with one, two, three and more haptic arms all have their advantages. For compactness and specificity, the rest of the description is directed to composite light adjustable intraocular lenses 100 with two haptic arms 114-1 and 114-2, but embodiments with other number of haptic arms are understood to be within the scope of the overall description.
  • FIGS. 2A-C illustrate a CLA IOL 100 where the light adjustable lens 120 can be attached to the IOL 110 at a proximal surface of the IOL 110.
  • proximal and distal are used in relation to the light incident from the pupil of the eye. Proximal indicates a position that is closer to the pupil.
  • the shown embodiments differ in the manner the haptics 114-1 and 114-2, again, cumulatively haptics 114, are attached to the components of the CLA IOL 100.
  • FIG.2A illustrates a CLA IOL 100, where the haptics 114 are attached to the IOL 110.
  • the chemical composition of the IOL 110 can include a fractional mixing of the chemical composition of the light adjustable lens 120.
  • Such an IOL 110 can include silicone-based monomers or macromers, forming polymers or copolymers, and possibly crosslinkers with the acrylate, an alkyl acrylate, an aryl acrylate, a substituted aryl acrylate, a substituted alkyl acrylate, a vinyl, or copolymers combining alkyl acrylates and aryl acrylates.
  • the first polymer matrix can include a siloxane based polymer, formed from macromer and monomer building blocks with an alkyl group, or an aryl group.
  • the first polymer matrix can include a fractional mixing of at least one of an acrylate, an alkyl acrylate, an aryl acrylate, a substituted aryl acrylate, a substituted alkyl acrylate, a vinyl, and copolymers combining alkyl acrylates and aryl acrylates. These can form at least one of polymers and copolymers with compounds of the first polymer matrix.
  • step 101c the swelling can be followed by applying a lock-in light with an essentially uniform radial profile and greater intensity to polymerize all remaining macromers.
  • this lock-in causes the light adjustable lens 120 to reach and to stabilize a shape that is swollen in its center, and therefore has a light-adjusted optical power.
  • the IOL 110 and the light adjustable lens 120 are adapted to retain a chemical separation even after they are attached.
  • This chemical separation can be achieved, e.g., by employing a refraction modulating composition in the light adjustable lens 120 that is not soluble in the materials of the IOL 110, and thus it does not diffuse into the IOL 110 from the light adjustable lens 120, in spite of the mobility of its constituent macromers in the first polymer matrix of the light adjustable lens 120 itself.
  • This attachment structure 135 can include a cylinder, a ring, an open tub, into which an optical element can be inserted, or a clasp, among others.
  • Such structures can have multiple advantages.
  • CLA IOLs 100 with an attachment structure 135 can be modular. This can be advantageous for pre-operative purposes, as a surgeon may need to keep a much smaller inventory. Once pre-operative diagnostics determines what IOL 110 needs to be paired with what light adjustable lens 120, the surgeon can select a separately stored IOL 110, and a separately stored light adjustable lens 120, and assemble the CLA IOL 100 by inserting the two selected lenses into the attachment structure 135.
  • the modularity can be advantageous post-operatively as well.
  • the surgeon needs to reopen the eye and remove the entire implanted CLA IOL 100, including its extended haptics 114.
  • Such a full-IOL removal can pose substantial challenges and can lead to undesirable medical outcomes, such as broken haptic pieces.
  • a modular CLA IOL 100 was implanted, then, upon the reopening of the eye the surgeon does not need to remove the entire CLA IOL 100, only the non-optimal IOL 110, and exchange it with a better selected IOL 110.
  • CLA IOLs 100 have the potential to deliver the promised vision improvements to the patients reliably. This benefit of the CLA IOLs 100 can start a fast expansion of the market acceptance and the market share of the advanced IOLs.
  • FIG. 7B illustrates that, after the end of the cataract surgery and the closing of the incisions, the implanted CLA IOL 100 may have rotated for a variety of reasons, so that the implanted rotated toric axis 204 of the implanted CLA IOL 100 makes an unintended rotational angle ⁇ with the target toric axis 202.
  • FIG.7C illustrates that the surgeon can devise and carry out an illumination procedure on the light adjustable lens 120 of the CLA IOL 100 to form a counter-rotating toric pattern 206, thereby causing a counter-rotation of the overall toric axis, so that the corrected toric axis 208 after the light adjustment procedure ends up pointing in the same direction as the originally planned target toric axis 202.
  • FIG. 8A illustrates the same procedure on the level of the cylinder patterns 212-218.
  • the surgeon in the pre-surgical planning phase of the cataract surgery may have decided that the cylinder vision problem of the patient shall be cured by implanting a CLA IOL 100 with a toric IOL 110, that has a target cylinder pattern 212, oriented as shown.
  • the CLA IOL 100 may have unintentionally rotated to an implanted rotated cylinder 214.
  • Such a misaligned, rotated cylinder 214 provides a much-reduced vision improvement, as explained previously.
  • the implanted rotated cylinder 214 can even turn into a net negative effect, being more a nuisance and disorientation than a benefit for the patient.
  • the surgeon can carry out a post- surgical diagnostic procedure to determine a corrective counter-rotating cylinder 216, the implementation of which can correct the unintended and unwanted rotation of the CLA IOL 100.
  • the surgeon can perform a light adjustment procedure of the light adjustable lens 120 of the CLA IOL 100 in order to create the counter-rotating cylinder 216 in the light adjustable lens 120.
  • the superposition of the implanted rotated cylinder 214 and the counter-rotating cylinder 216 can sum up into a shape of the light adjustable lens having a corrected cylinder 218, whose direction is aligned with the direction of the originally planned target cylinder 212.
  • FIG. 8B illustrates the same procedure in a geometric language, where the cylinder patterns are represented by corresponding vectors.
  • the directions of the vectors are indicative of the directions of the represented cylinders, and the magnitudes of the vectors can represent the strength, curvature, or diopters of the cylinders.
  • the target toric vector 222 represents the target cylinder 212
  • the implanted rotated toric vector 224 represents the implanted rotated cylinder 214 of the CLA IOL 100 after implantation.
  • the surgeon post-operatively can determine the counter-rotating toric vector 226, representing the counter-rotating cylinder 216, necessary to correct the unintended post-surgical rotation of the toric IOL 110.
  • FIG. 8C illustrates in the language of the vector representation that there can be different ways to bring about the necessary correction.
  • the correctional pattern can include a reductional toric vector 227 that reduces, or even eliminates, the implanted rotated toric vector 224.
  • the counter-rotating toric vector 226 can then be chosen to rotate the remaining portion of vector 224 (that is equal to the sum of the vectors 224 and 227) into the corrected toric vector 228.
  • the light adjustable lens 120 can be adapted to be able to correct a cylinder up to 2D. For example, if the toric IOL 110 was intended to correct a 6D cylinder, but the toric axis was rotated by 10 degrees, this translates into a 30% reduction of efficiency, as described earlier, providing a net 4D cylinder improvement for the patient.
  • FIG.9 illustrates the steps of a corresponding method 230 of adjusting an implanted composite light adjustable intraocular lens 100 in more general terms.
  • the method 230 can include the following steps. 231 - Planning a targeted optical outcome of an implantation of a composite light adjustable intraocular lens into an eye. 232 - Implanting the composite light adjustable intraocular lens into the eye.
  • FIGS. 10-11 illustrate an embodiment of the CLA IOL 100 that provides the additional medical benefit of chromatic aberration reduction.
  • this chromatic dispersion of the eye tissues causes the short wavelength (“blue”) components of an image focused and imaged proximal the retina, while the long wavelength (“red”) components focused distal to the retina, thereby causing some degree of blurring and image quality deterioration.
  • This blurring of the color-components of the image is often referred to as chromatic aberration.
  • the typically negative ⁇ n l / ⁇ 0 translates to a negative ⁇ P l / ⁇ 0, whereas for negative optical powers, the negative ⁇ n l / ⁇ 0 translates to a positive ⁇ P l / ⁇ 0.
  • an intraocular lens can compensate chromatic aberrations, if the wavelength derivative of its optical power compensates the negative wavelength derivative of the eye optical power, so that ⁇ P l / ⁇ + ⁇ P e / ⁇ ⁇ 0. In other words, ⁇ P l / ⁇ ⁇ - ⁇ P e / ⁇ >0.
  • embodiments of the CLA IOL 100 are made of two different lenses, the IOL 110, and the light adjustable lens 120.
  • Such two-lens designs introduce a genuinely new possibility.
  • One of the lenses of the CLA IOL 100 can have a negative optical power and thus a strongly positive ⁇ P/ ⁇ >0, so that the combined, two-lens CLA IOL 100 can compensate the chromatic aberration of the eye optical system, while the combined optical powers of the two lenses can still perform the primary function of the intraocular lens, to deliver an about constant 20D.
  • FIGS. 10A-B show embodiments of the CLA IOL 100 which deliver such reduced chromatic aberrations.
  • the negative optical power lens is often referred to as a “flint”, the positive optical power lens as a “crown”. If the composite lens itself exhibits near zero chromatic aberration, then the CLA IOL 100 can be called an “achromat”. If the composite lens makes a larger assembly, such as the CLA IOL 100 plus the eye, exhibit near zero chromatic aberration, then the CLA IOL 100 can be called an “achromator”.
  • FIG. 10A-B show embodiments of the CLA IOL 100 which deliver such reduced chromatic aberrations.
  • FIG. 10A shows an embodiment where the IOL 110, having a negative optical power P IOL ⁇ 0, is the flint, and the light adjustable lens (LAL) 120, having a positive optical power P LAL >0, is the crown.
  • FIG. 10B illustrates an opposite embodiment, where the IOL 110 has a positive power P IOL >0, and the light adjustable lens 120 has a negative power P LAL ⁇ 0.
  • CLA IOLS 100 embodiments with the design of FIG. 10A, where the negative power IOL 110 is made of PMMA, or other acrylates or analogs, and the positive power light adjustable lens 120 is made of silicone, can reduce the chromatic aberration efficiently.
  • PMMA IOL 110 can be given a low and negative optical power, such as P IOL ⁇ — 10D), while the low
  • FIG. 11 illustrates the above concepts in the language of the chromatic shifts.
  • the chromatic shift characterizes the distance of the image from the target/image plane (in the case of the eye, from the retina), expressed in diopters.
  • a negative chromatic shift represents that the image was formed proximal, in front of the retina, whereas a positive chromatic shift that the image was formed distal, behind the retina.
  • the chromatic shift increasing with the wavelength represents that the optical power decreases with the wavelength: ⁇ P / ⁇ 0.
  • the IOL 110 has an IOL chromatic shift variation;
  • the light adjustable lens 120 has a light adjustable lens chromatic shift variation;
  • an eye, with a crystalline lens removed, has an eye chromatic shift variation;
  • a chromatic shift variation of the eye, with the composite light adjustable intraocular lens 100 implanted can be less than a chromatic shift variation of the eye with the crystalline lens in place, wherein the chromatic shift variation is defined from a difference of a chromatic shift at 450 nm and at 650 nm.
  • an optical power of the IOL 110 can be negative; an optical power of the light adjustable lens 120 can be positive; and the chromatic shift variation of the eye, with the composite light adjustable intraocular lens implanted, can be less than 0.5D. In other embodiments, this chromatic shift variation can be less than 0.2D.
  • the blurriness of the image, caused by the chromatic dispersion can be substantially smaller than that of the natural eye, thereby sharpening the vision in an additional aspect: a clear further medical benefit.
  • PCOs are fibrous, or pearl-like, or a combination of both.
  • PCO can be detected as a wrinkling on the posterior capsule, for example.
  • the development of PCO often involves three basic phenomena: proliferation, migration and differentiation of residual LECs.
  • forming a sharp mechanical barrier in contact with the capsular bag 15 was also shown to reduce PCO. Such a barrier suppresses the fibrous growth and reduces LEC migration, thereby reducing PCO.
  • FIG.12A and FIG.12B illustrate that there can be several combinations and designs of the CLA IOL 100 that press the capsular bag 15 with higher than usual force.
  • the sequence of the IOL 110 and the light adjustable lens 120 can be reversed.
  • the materials of the flint and the crown can be exchanged.
  • the adhesion promoter 300 can include a first orthogonal functional group, configured to bond with an acrylic component of the acrylic intraocular insert 110’; and a second orthogonal functional group, configured to bond with a silicone component of the silicone- based light adjustable lens 120, as described below in detail.
  • the silicone-based light adjustable lens 120 is sometimes abbreviated as light adjustable lens 120, or LAL 120.
  • the acrylic intraocular insert 110’ can include the intraocular lens (IOL) 110 with an optical power and can be thought of as an embodiment of the IOL 110.
  • the acrylic intraocular insert 110’ can include a carrier with approximately zero optical power.
  • the intraocular lens (IOL) 110 can be thought of as an embodiment of the acrylic intraocular insert 110’, with, or without an optical power.
  • These embodiments include the adhesion promoter 300 to ensure that the two main constituents of the composite light adjustable IOL 100, the acrylic intraocular insert 110’ and the silicone-based light adjustable lens 120 are chemically bonded together and do not peel apart after implantation and the light adjustment procedure.
  • the silicone-acrylic joint needs to be stress-tolerant, resisting the light-induced tensions to the necessary degree, including resisting the tendencies of the silicone-based light adjustable lens 120 peeling away from the acrylic intraocular insert 110’ as a result of the light adjustment.
  • This is a particularly demanding expectation, as implanted CLA IOLs 100 with peeled-apart components cannot be discarded.
  • the silicone forms a frame, or a biasing element, or is positioned around the edges of the acrylic IOL. In such IOLs, the silicone-acrylate interface is not within the optical path, and therefore there is not much of a requirement for the silicone-acrylic joint to not distort the imaging quality.
  • FIGS.14A-C illustrate point (1) above regarding the difference of the here-described CLA IOLs 100 from previous systems, driven by the light adjustability of the silicone-based LAL 120.
  • FIG.14A illustrates the application of the refraction modulating illumination to the CLA IOL 100.
  • FIG.14B illustrates that in response to this illumination, the silicone-based LAL 120 of the CLA IOL 100 changes its shape.
  • the refraction modulating illumination unavoidably induces tension and strain at the interface of the acrylic intraocular insert 110’ and the silicone- based LAL 120.
  • This strain and tension are induced only after the fabrication process and after the implantation, thus cannot be eliminated by changes in fabrication.
  • CLA IOLs 100 require an adhesion promoter 300 that chemically bonds the two surfaces together with sufficient strength to prevent the separation of the acrylic intraocular insert 110’ and the silicone-based LAL 120, in spite of the tensions and strain induced by the shape change caused by the refraction modulating illumination.
  • embodiments of the acrylic intraocular insert 110’ can comprise at least one of a monomer, a macromer, an oligomer, and a polymer, selected from the group consisting of an acrylate, an alkyl acrylate, an aryl acrylate, a substituted aryl acrylate, a substituted alkyl acrylate, a halogen substituted acrylate, a halogen substituted methacrylate, an acrylic ester or acrylic acid, an acrylamide, a vinyl, and copolymers combining alkyl acrylates and aryl acrylates.
  • crosslinkers with corresponding bis- or multi-functionality can be present to aid the polymerization.
  • the crosslinker can be ethylene glycol dimethacrylate, tetraethylene glycol dimethacrylate, propylene glycoldimethacrylate and propylene glycoldiethacrylate.
  • the crosslinked network can be induced by thermal, UV-initiated, or catalyst-promoted reactions.
  • thermal initiators can be 2,2-azobis(2,4-dimethylpentanitrile), 2,2-azobis(2,4-dimethylbutanenitrile), azobisisobutyro- nitrile, azobisisopropionitrile, or azobisisomethylpropionitrile.
  • photo initiators can be benzophenones, benzoin alkyl ethers, benzil ketals, phosphine oxides, acyl oxime esters, acetophenones or acetophenone derivatives.
  • the silicone-based light adjustable lens 120 can include a first polymer matrix and a refraction modulating composition, dispersed in the first polymer matrix, wherein the refraction modulating composition is capable of stimulus-induced polymerization that modulates a refraction of the silicone-based light adjustable lens 120.
  • the first polymer matrix can include a siloxane-based polymer, formed from macromer and monomer building blocks with at least one of an alkyl group and an aryl group.
  • the CLA IOL 100 can include a photoinitiator, configured to be activated upon absorbing a refraction modulating illumination; and to initiate the stimulus-induced polymerization of the refraction modulating compound.
  • CLA IOLs 100 can include an ultraviolet absorber.
  • FIGS.16A-B illustrate different ways of incorporating the adhesion promoter 300 into the CLA IOL 100.
  • FIG.16A illustrates that in some CLA IOLs 100, the adhesion promoter 300 can be dispersed in the acrylic intraocular insert 110’.
  • FIG.16B illustrates that in some CLA IOLs 100 the adhesion promoter 300 can be dispersed in an adhesion layer 310 between the acrylic intraocular insert 110’ and the silicone-based light adjustable lens 120.
  • the adhesion promoter 300 can be dispersed in the silicone-based light adjustable lens 120.
  • the adhesion promoter 300 can be dispersed in some combination of the embodiments of FIGS.17A-C.
  • FIGS.17A-C illustrate these same embodiments of inclusion in a somewhat different manner.
  • FIG.17A illustrates the embodiments of FIG.16A, where the adhesion promoter 300 is primarily dispersed in the acrylic intraocular insert 110’, bonded to the silicone-based LAL 120 with silicon-carbon covalent bonds 320, and bonded to acrylates of the acrylic intraocular insert 110’ with bonds 322.
  • the circles are schematic representations of the first orthogonal functional group configured to bond with an acrylic component of the acrylic intraocular insert 110’ with bonds 322.
  • the triangles are schematic representations of the second orthogonal functional group, configured to configured to bond with a silicone component of the silicone-based light adjustable lens 120 with covalent bonds 320.
  • Both orthogonal functional groups schematically represented by the circles and the triangles, are selected to uniquely bond with their complementary counterparts.
  • FIG. 17B illustrates the embodiments of FIG. 16B, where the adhesion promoter 300 is primarily dispersed in the adhesion layer 310, bonded to the silicone-based LAL 120 with covalent chemical bonds 320, and bonded to the acrylates of the acrylic intraocular insert 110’ with bonds 322.
  • FIG. 17B illustrates the embodiments of FIG. 16B, where the adhesion promoter 300 is primarily dispersed in the adhesion layer 310, bonded to the silicone-based LAL 120 with covalent chemical bonds 320, and bonded to the acrylates of the acrylic intraocular insert 110’ with bonds 322.
  • the adhesion promoter 300 is primarily dispersed in the silicone-based LAL 120, bonded to the silicone-based LAL 120 with covalent chemical bonds 320, and bonded to the acrylates of the acrylic intraocular insert 110’ with bonds 322.
  • the adhesion promoter 300 can contain the two orthogonal functional groups that can independently participate in polymerization using their unique chemistries: the first orthogonal functional group, configured to bond with an acrylic component of the acrylic intraocular insert 110’, and the second orthogonal functional group, configured to bond with a silicone component of the silicone-based light adjustable lens 120.
  • R1 is methyl
  • R2 is propyl
  • R3, R3’ and R3” each is vinyl dialkylsiloxy
  • R4 and R5 each is a C1-10 alkyl chain
  • R6 is vinyl.
  • R2 can be a chain, in others, a branched, or a cyclic isomer of an alkyl spacer, such as cyclopentyl.
  • R2 can be a substituted vinyl aryl.
  • R2 may also have a substituted aromatic group such as a substituted phenyl or a substituted naphthyl.
  • the first orthogonal functional group to the left of R2 forms the covalent bond 322 with the acrylic intraocular insert 110’.
  • the second orthogonal functional group is R6 that forms the covalent bond 320 with the silicone-based LAL 120 via the double bond interacting with silicone hydride to form a new covalent silicone carbon bond 320.
  • Adhesion promoters 300 with more double bonds form more covalent bonds 320 with the silicone-based LAL 120. The number of available double bonds can be increased by selecting two or all three of R3, R3’ and R3” to be a vinyl dialkylsiloxy pendant group, each containing an R6 with a double bond. The resulting adhesion promoter 300 is shown in structure (3).
  • This embodiment of the adhesion promoter 300 is called methacryloxypropyltris (vinyldimethylsiloxy)silane, with structure (3), where R1 is methyl, R2 is propyl, the R3, R3’ and R3” are vinyldimethilsiloxy, R4 and R5 are methyl, and R6 is vinyl.
  • This structure (3) is a suitable an adhesion promoter 300, since it contains 3 vinyl R6s, each with a double bond, and thus is capable of bonding to the silicone-based LAL 120 with multiplied strength, which is promising for preventing the peeling between the acrylic intraocular insert 110’ and the silicone-based LAL 120, and the optical distortions at their interface, as discussed above.
  • the overall strength of the adhesion between the acrylic intraocular insert 110’ and the silicone-based LAL 120, generated by the adhesion promoter 300 depends on the strength and number of the covalent bonds 320 per individual adhesion promoter molecule, as well as on the concentration of these molecules. It has been found that a concentration of the methacryloxypropyltris(vinyldimethylsiloxy)silane as adhesion promoter 300 above 5 weight% dispersed in the acrylic intraocular insert 110’ was sufficient (1) to prevent peeling between the acrylic intraocular insert 110’ and the silicone-based LAL 120 even after the refraction modulating illumination, and (2) to avoid the generation of optical distortions by the acrylic intraocular insert 110’ -- silicone-based LAL 120 interface.
  • CLA IOLs 100 with a concentration above 10 weight% performed particularly well.
  • a concentration higher than 10 weight% was found to provide sufficient quality bonding.
  • Structure (3) can be viewed as a monomer unit within the formulation of acrylic intraocular insert 110’, where it can act as an adhesion promoter 300.
  • the corresponding building block can be methacryloxypropyldi(vinyldimethylsiloxy)methylsilane, methacryloxypropyl(vinyldimethylsiloxy)dimethylsilane, acryloxypropyltris(vinyldimethylsiloxy)silane, methacryloxybutyltris(vinyldimethylsiloxy)silane, acryloxybutyltris(vinyldimethylsiloxy)silane, acryloxypropyldi(vinyldimethylsiloxy)methylsilane, methacryloxybutyldi(vinyldimethylsiloxy)methylsilane, acryloxybutyldi(vinyldimethylsiloxy)methylsilane, acryloxypropyl(vinyldimethylsiloxy)dimethylsilane, methacryloxybutyl(vinyldimethylsiloxy)dilane,
  • FIGS.18A-B illustrates that in some CLA IOLs 100 the silicone-based light adjustable lens 120 is attached to the acrylic intraocular insert 110’ at a proximal surface of the acrylic intraocular insert 110’.
  • the acrylic intraocular insert 110’ can include an ultraviolet absorbing material dispersed throughout the acrylic intraocular insert 110’, or an ultraviolet (UV) absorbing layer 340.
  • This UV absorbing layer 340 can be at a proximal surface of the acrylic intraocular insert 110’, as in FIG.18A, or at a distal surface of the acrylic intraocular insert 110’, as in FIG.18B.
  • the CLA IOL 100 of FIG.18A can be equivalently characterized as the ultraviolet absorbing layer 340 being formed at a distal surface of the silicone-based light adjustable lens 120. All these embodiments can be helpful to further increase the retinal safety of the refraction modulation illumination.
  • the silicone-based light adjustable lens 120 can be attached to the acrylic intraocular insert 110’ by at least one of a chemical reaction, a thermal treatment, an illumination treatment, a polymerization process, a molding step, a curing step, a lathing step, a cryo-lathing step, a mechanical process, an application of an adhesive, and by a combination thereof.
  • FIGS.19A-B illustrate that the acrylic intraocular insert 110’ having an optical power can include a diffractive structure 350 to induce this optical power, as was mentioned before.
  • This diffractive structure 350 can be at the distal surface of the acrylic intraocular insert 110’, as shown. In other cases, the diffractive structure 350 can be at the proximal surface of the acrylic intraocular insert 110’, facing the silicone-based LAL 120. This latter design reduces the halo and glare, characteristic of diffractive IOLs.
  • the acrylic intraocular insert 110’ can be a toric acrylic intraocular insert 110’. This toric acrylic intraocular insert 110’ can have an optical power in some embodiments.
  • the refraction modulating illumination has competing effects on the two surfaces of the silicone-based LAL 120.
  • the radius of curvature of the proximal surface of the silicone-based LAL 120 can decrease, thereby increasing its optical power.
  • the same illumination can increase the radius of curvature of the distal surface, decreasing the optical power of the silicone-based LAL 120.
  • Embodiments of the CLA IOL 100 attach the distal surface of the silicone-based LAL 120 to the IOL 110, or to the acrylic intraocular insert 110’.
  • This attachment increases the rigidity and resistance of the distal surface of the silicone-based LAL 120 against curvature changes, thereby reducing the competition against the optical power increase induced by the proximal surface of the silicone-based LAL 120. Reducing the distal surface curvature change is one more beneficial effect of CLA IOLs 100, as it reduces the radiance of the illumination necessary to achieve a planned optical power change, thereby further increasing retinal safety.
  • a widely used design for IOLs is to redirect the light by forming a diffractive pattern on a surface of the IOL, as mentioned before in relation to FIGS. 19A-B.
  • FIG. 20 shows the concept of such a diffractive IOL.
  • a diffractive IOL 110 has a diffractive structure 350 that has a set of annuli, rings, or diffractive steps/zones 403i, where each ring supports a rising surface segment.
  • FIGS. 21A-C illustrate different embodiments of diffractive IOL 110.
  • FIG. 21A illustrates a monofocal diffractive IOL 110 which has a single focal point 404 where the rays, diffracted into the leading diffraction peak intersect.
  • FIG. 21B illustrates a bifocal design that offers additional medical benefits.
  • a fraction of the light is diffracted in the direction of the leading-order diffraction peak, converging in the leading focal point as in FIG.21A, while most of the remaining fraction is diffracted in the direction of another diffraction peak of the diffractive structure 350, and thus converges in a second focal point.
  • the diffractive structure 350 is designed so that the fraction of the light intensity directed to the second focal point can be substantial, such as 30-40% of the total light intensity.
  • the lead distant focal point 404d often related to the zeroth diffraction order, is selected to focus distant objects to the retina.
  • the near focal point 404n related to the next-to-leading diffraction order is selected to focus near objects (at a distance of around 40 cm) to the retina.
  • one of the benefits of such diffractive bifocal IOLs is that since they create the second, near focal point 404n with the entire surface of the IOL, the visual experience of the patient is not particularly sensitive to the pupil diameter. This is in contrast to “zonal” IOLs, which use only a peripheral annular surface segment, or zone, to focus light to their near focal point 404n. In these zonal IOLs the portion of light refracted to the near focal point 404n, and thus the visual acuity, is quite sensitive to the pupil diameter.
  • FIGS. 21C illustrates that the concept of generating additional focal points with diffractive structures on the IOL has been extended further with the introduction of trifocal lenses.
  • Trifocal IOLs use three diffractive orders to focus portions of the light to a distant focal point 404d, to a near focal point 404n, and to an intermediate focal point 404i. This latter is designed to focus light to the retina coming from intermediate distances, such as 80 cm-100 cm.
  • the intermediate focal point 404i is often positioned about halfway, “symmetrically” between the near focal point 404n and the distant focal point 404d – when measured in the widely used inverse length unit of diopters.
  • some diffractive IOLs 110 have the diffractive structure on their front, or proximal surface, while others on their back, or distal surface, as shown in FIGS. 21A-C. Both of these embodiments can achieve the here-described benefits. [0149]
  • all these diffractive IOLs 110 share the drawbacks of traditional IOLs as listed earlier, and have some additional problems on their own, as listed below. We start with presenting the known limitations of the existing IOL technologies, a list that includes limitations listed earlier.
  • a CLA IOL 100 is adjustable. Therefore, an adjustment by illumination after the cataract surgery can correct any post-surgical tilt, shift, rotation and movement of the IOL, thereby guaranteeing an essentially optimal outcome.
  • B2. The adjustability of a CLA IOL 100 reduces, and often eliminates the necessity of expensive and extensive diagnostic pre-surgical examinations, because patient dissatisfaction with the outcome of the surgery can be corrected after the surgery with a light adjustment of the CLA IOL 100.
  • the toric prescription can be induced by irradiation after the implantation of a CLA IOL 100.
  • the direction and magnitude of this post-surgically induced toricity will be aligned and set by the prescription with excellent precision.
  • This feature also simplifies manufacturing and inventory, since presently often 5-10 diffractive IOLs of the same sphere prescription have to be supplied by the manufacturer and stored by the ophthalmologist to cover all possible toric prescriptions. It is noted that some of the toric prescriptions can be implemented in the acrylic diffractive IOL to extend the range of correction of the higher levels of astigmatism, which are less sensitive to prediction errors of axis.
  • acrylate-based IOLs have softer elastic constants and more favorable viscoelastic character, and thus unfold slower during the insertion. This aspect allows the surgeon to exercise more control over the insertion of acrylate IOLs. Thus, acrylic CLA IOLs 100 are less “springy” and unfold more smoothly.
  • B5. Some existing LALs are three-piece: the two haptics are often separately fabricated and subsequently inserted into the central lens body. This design feature increases manufacturing costs, may lead to a higher rate of haptics misalignment during manufacture, and to separation of the haptics from the LAL lens body during the insertion.
  • CLA IOLs 100 with a one-piece design acrylic diffractive IOL 110, with their haptics molded from the acrylic itself, can achieve all these benefits.
  • Further benefits are associated with a particular CLA IOL design, where the LAL 120 is proximal/frontal/anterior, and the acrylic diffractive IOL 110 is posterior.
  • the LAL technology protects the retina from UV exposure by employing the UV absorbing layer 130 formed posterior to the LAL 120. Manufacturing this UV absorbing layer 130 involves an additional manufacturing step with its own challenges.
  • CLA IOLs can eliminate the need for forming the separate UV blocking layer 130 by dispersing the same UV blocking material in the acrylic diffractive IOL 110 itself.
  • Silicone LALs 120 can be contraindicated in patients who likely would need retinal vitrectomy surgery since it tends to be difficult to visualize retinal troughs during surgery if air or silicone oil is inserted into vitreous cavity.
  • These diffractive IOLs 110 have a central lens, and haptics 114-1 and 114-2.
  • the central lens has a diffractive structure 350, which is illustrated from a side view in the lower part of the figure.
  • a particularly notable class of the diffractive IOL 110 embodiments are diffractive IOLs 110 with a suppressed diffractive order.
  • FIGS. 21A-C illustrate the light propagation in the diffractive IOLs 110.
  • the diffractive structure 350 is formed on the frontal/anterior surface of the diffractive IOL 110, in others on the back/posterior surface.
  • the intermediate focal point 404i is often positioned about halfway, “symmetrically” between the near focal point 404n and the distant focal point 404d – when measured in the widely used inverse length unit of diopters.
  • the optical power corresponding to the intermediate focal point 404i differs by about 1.0-1.25D from both the distant and the near optical powers.
  • FIGS.22A-B illustrate a particularly successful trifocal design, Alcon’s Panoptix.
  • the diffractive IOL 110 includes a diffractive structure 350 that comprises individual diffractive steps, or zones, 403i that diffract the incoming light rays into diffractive orders.
  • FIGS.23A-B illustrate that in some CLA IOLs 100, the silicone light adjustable lens 120 is proximal to the acrylic diffractive IOL 110.
  • FIG.24 illustrates that in some CLA IOLs 100, the silicone light adjustable lens 120 is distal to the acrylic diffractive IOL 110.
  • the first polymer matrix can include a siloxane-based polymer, formed from macromer and monomer building blocks with at least one of an alkyl group and an aryl group.
  • the silicone light adjustable lens 120 can include a photoinitiator, to absorb a refraction modulating illumination; to be activated upon the absorption of the illumination; and to initiate the polymerization of the refraction modulating compound.
  • the silicone light adjustable lens 120 can further include at least one of an ultraviolet-absorber dispersed throughout; and an ultraviolet absorbing layer at a distal surface of the silicone light adjustable lens 120, like the UV absorbing layer 130 of FIG.5, and the analogous UV absorbing layer 340 of FIGS.18A-B.
  • the acrylic diffractive IOL 110 can include at least one of an ultraviolet-absorber dispersed throughout; and an ultraviolet absorbing layer at a distal surface of the acrylic diffractive IOL 110.
  • FIG.22B and FIG.25 illustrate that the diffractive structure 350 of the diffractive IOL 110 can produce constructive interference in at least four consecutive diffractive orders corresponding a range of vision from near to distance vision, wherein the constructive interference produces a near focal point, a distance focal point, corresponding to the base power of the ophthalmic lens, and an intermediate focal point between the near focal point and the distance focal point and wherein a diffraction efficiency of at least one of the diffractive orders is suppressed to less than ten percent.
  • the four consecutive diffractive orders are (0, +1, +2, +3), and suppressed diffractive order is the +1 diffractive order.
  • this suppressed diffractive order has a diffraction efficiency of 3%, which is an embodiment of the diffractive peaks being suppressed to less than 10%. Since the 1 st diffractive order next to the 0 th order, corresponding to the distant focal point 404d, is suppressed in this CLA IOL 100, in this embodiment the intermediate focal point 404i is asymmetrically closer to the near focal point 404n.
  • the four consecutive diffractive orders include a lowest diffractive order, a highest diffractive order, and two intermediate diffractive orders; and the suppressed diffractive order is one of the two intermediate diffractive orders.
  • FIG.26 illustrates that in some CLA IOLs 100, the silicone light adjustable lens 120 is attached to the acrylic diffractive intraocular lens 110 with an adhesion promoter 300.
  • adhesion promoter 300 Embodiments of the adhesion promoter 300 that were described in relation to FIGS.13-19 can be also implemented in this embodiment of FIG.26, where the acrylic intraocular insert 110’, or IOL 110 is diffractive.
  • the adhesion promoter 300 has the structure at least one of R3, R3’ and R3” is a vinyl dialkylsiloxy pendant group with the structure ; the remaining of R3, R3’ and R3” are independently selected from the group consisting of C1-C10 pendant alkyl groups, such as methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl; the first orthogonal functional group is the functional group to the left of R 2 ; the second orthogonal functional group is R 6 ; R 1 is selected from the group consisting of a hydrogen, a monovalent hydrocarbon group, and a substituted C1-C12 alkyl, wherein the alkyl can be methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-but
  • FIG. 28 illustrates yet another variant embodiment of the CLA IOL 100.
  • the diffractive structure 350 can be formed on the light adjustable lens 120, forming a diffractive light adjustable lens 120’, as shown.
  • Such composite light adjustable intraocular lenses 100 can comprise an acrylic intraocular lens 110 and a diffractive silicone light adjustable lens 120’, attached to the acrylic intraocular lens 110, the diffractive silicone light adjustable lens 120’ having a diffractive structure 350. All descriptions of the previous embodiments, presented in relation to FIGS.1-27 can be adapted to, or combined with the present embodiment of FIG.28.

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Abstract

L'invention concerne une lentille intraoculaire composite réglable par la lumière comprenant une lentille intraoculaire diffractive acrylique, présentant une structure diffractive et un caractère haptique ; et une lentille en silicone réglable par la lumière, fixée à la lentille intraoculaire diffractive acrylique. La structure diffractive produit une interférence constructive dans au moins quatre ordres de diffraction consécutifs correspondant à une plage de vision entre une vision de près et une vision de loin, l'interférence constructive produisant un point focal proche, un point focal à distance correspondant à la puissance de base de la lentille ophtalmique et un point focal intermédiaire entre le point focal proche et le point focal à distance et une efficacité de diffraction d'au moins l'un des ordres de diffraction étant supprimée à moins de dix pour cent.
EP22756734.4A 2021-02-21 2022-02-11 Lentille intraoculaire composite réglable par la lumière à structure diffractive Pending EP4294325A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US17/180,790 US20210251744A1 (en) 2017-05-29 2021-02-21 Composite light adjustable intraocular lens with diffractive structure
PCT/US2022/016131 WO2022177821A1 (fr) 2021-02-21 2022-02-11 Lentille intraoculaire composite réglable par la lumière à structure diffractive

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US8222360B2 (en) * 2009-02-13 2012-07-17 Visiogen, Inc. Copolymers for intraocular lens systems
US9622855B2 (en) * 2012-10-08 2017-04-18 Valdemar Portney Remote multifocal to monofocal optic conversion
US9335564B2 (en) * 2014-05-15 2016-05-10 Novartis Ag Multifocal diffractive ophthalmic lens using suppressed diffractive order
US10966819B2 (en) * 2017-05-29 2021-04-06 Rxsight, Inc. Composite light adjustable intraocular lens

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CN116867464A (zh) 2023-10-10
JP2024507815A (ja) 2024-02-21
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CA3208477A1 (fr) 2022-08-25
WO2022177821A1 (fr) 2022-08-25

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