Composite photoaccommodating intraocular lens with adhesion promoter

Abstract

The hybrid photoaccommodating intraocular lens has an acrylic intraocular insert, a silicone-based photoaccommodating lens attached to the acrylic intraocular insert by an adhesion promoter, and haptics, the adhesion promoter including a first orthogonal functional group configured to bond with an acrylic component of the acrylic intraocular insert and a second orthogonal functional group configured to bond with a silicone component of the silicone-based photoaccommodating lens.

Description

[Technical Field]

[0001] The present invention relates to photoaccommodative intraocular lenses, and more particularly to illuminated, accommodative hybrid intraocular lenses.

[0002] REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of co-pending U.S. patent application Ser. No. 15 / 607,681, entitled "Composite Light Adjustable Intraocular Lens," filed by I. Goldshleger, J. Kondis, R.M. Kurtz, and R. Shrestha, which is incorporated by reference in its entirety. [Background technology]

[0003] Recently, cataract surgery technology has continuously and dramatically improved. Next-generation phacoemulsification platforms and newly invented surgical lasers continue to improve intraocular lens (IOL) placement accuracy and reduce undesirable medical outcomes. Current-generation IOLs based on soft acrylate materials also offer excellent visual outcomes and numerous additional medical advantages, including ease and control of the implantation process and advantageous haptic designs.

[0004] Nevertheless, even the latest generation of devices and IOLs continue to present several types of challenges. One of these challenges is that despite surgeons' meticulous preoperative diagnostics and optimal IOL implantation decisions, a significant number of postoperative outcomes are suboptimal. This may be due to a variety of factors, including variations in the healing process of the incision, which can tilt or displace the implanted IOL, or imperfect eye modeling, among others.

[0005] Recent achievements have been remarkable with the development of noninvasively accommodating lenses after cataract surgery. These lenses contain a photosensitive material that photopolymerizes upon activation by irradiation. Irradiation with a carefully designed radial profile initiates photopolymerization with a corresponding radial profile, which further alters the physical shape of the IOL and, therefore, its optical power. These photoaccommodating lenses hold great promise for adjusting and eliminating residual postoperative malpositioning and for postoperative noninvasive fine-tuning of the IOL's "final diopter." Summary of the Invention [Problem to be solved by the invention]

[0006] However, the current generation of these photoaccommodating lenses still allows for further improvement, including optimal material properties that can mitigate implantation issues and good haptic design practices.

[0007] Thus, there exists an unmet medical need for an intraocular lens that offers the benefits of both today's standard acrylate and photoaccommodating IOLs while minimizing the undesirable performance aspects of these IOLs. [Means for solving the problem]

[0008] In this patent document, the above-mentioned needs are met by embodiments of a hybrid photoaccommodating intraocular lens, which may include an intraocular lens (IOL), a photoaccommodating lens attached to the intraocular lens, and haptics. In some cases, the hybrid photoaccommodating intraocular lens may include an intraocular lens and haptics attached to the IOL by a photoaccommodating hinge. A method for accommodating an implanted hybrid photoaccommodating intraocular lens may include planning a target visual outcome for implanting the hybrid photoaccommodating intraocular lens in an eye, implanting the hybrid photoaccommodating intraocular lens in the eye, performing diagnostic measurements to evaluate an implanted visual outcome of the implantation step, determining a correction based on a comparison of the planned visual outcome to the implanted visual outcome, and providing a stimulus to adjust the optical properties of the hybrid photoaccommodating intraocular lens to cause the determined correction. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a plan view of a compound photoaccommodating IOL. [Figure 2A] FIG. 1 is a side view of an embodiment of a hybrid photoaccommodating IOL, or CLA·IOL. [Figure 2B] FIG. 1 is a side view of an embodiment of a hybrid photoaccommodating IOL, or CLA·IOL. [Figure 2C] FIG. 1 is a side view of an embodiment of a hybrid photoaccommodating IOL, or CLA·IOL. [Figure 3] FIG. 10 is a side view of another embodiment of a compound photoaccommodating IOL. [Figure 4] FIG. 1 illustrates steps of a light adjustment procedure. [Figure 5] 1A-1C illustrate an embodiment of a hybrid photoaccommodating IOL including a UV absorbing layer. [Figure 6] FIG. 1 shows a CLA·IOL including attachment structures. [Figure 7A] Figure 1 shows the formation of a counterrotational toric pattern in an implanted rotated toric CLA·IOL. [Figure 7B]Figure 1 shows the formation of a counterrotational toric pattern in an implanted rotated toric CLA·IOL. [Figure 7C] Figure 1 shows the formation of a counterrotational toric pattern in an implanted rotated toric CLA·IOL. [Figure 8A] FIG. 10 illustrates the creation of similar counter-rotating cylinders using vector formulation. [Figure 8B] FIG. 10 illustrates the creation of similar counter-rotating cylinders using vector formulation. [Figure 8C] FIG. 10 illustrates the creation of similar counter-rotating cylinders using vector formulation. [Figure 9] FIG. 1 illustrates a method of accommodation for a compound photoaccommodative IOL. [Figure 10A] FIG. 1 shows a CLA·IOL for reducing chromatic aberration. [Figure 10B] FIG. 1 shows a CLA·IOL for reducing chromatic aberration. [Figure 11] Figure 1 shows the color shift of the CLA·IOL compared to a standard IOL. [Figure 12A] 10A-10C illustrate the PCO suppression aspects of an embodiment of a chromatic aberration correction of a hybrid photoaccommodating IOL. [Figure 12B] 10A-10C illustrate the PCO suppression aspects of an embodiment of a chromatic aberration correction of a hybrid photoaccommodating IOL. [Figure 13] 1A-1C illustrate an embodiment of a hybrid photoaccommodating IOL including an adhesion promoter. [Figure 14A] FIG. 1 is a cross-sectional view of an embodiment of a hybrid photoaccommodating IOL. [Figure 14B] FIG. 1 is a cross-sectional view of an embodiment of a hybrid photoaccommodating IOL. [Figure 14C] FIG. 1 is a cross-sectional view of an embodiment of a hybrid photoaccommodating IOL. [Figure 15A] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 15B] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 16A] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 16B] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 17A] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 17B] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 17C] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL including adhesion promoters with different incorporation methods of adhesion promoters. [Figure 18A] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL that include UV absorbing layers at different locations. [Figure 18B] 1A-1C illustrate embodiments of a hybrid photoaccommodating IOL that include UV absorbing layers at different locations. [Figure 19A] 1A-1C show an embodiment of a hybrid photoaccommodating IOL with an acrylic intraocular insert having diffractive structures. [Figure 19B] 1A-1C show an embodiment of a hybrid photoaccommodating IOL with an acrylic intraocular insert having diffractive structures. DETAILED DESCRIPTION OF THE INVENTION

[0010] Existing photoaccommodating intraocular lenses are often made from silicone-based polymers such as polysiloxanes and corresponding copolymers. Existing non-photoaccommodating intraocular lenses are often made from various acrylates. The problems (L) and advantages (B) of these two classes of IOLs include:

[0011] (L1) The elastic constants of silicone-based IOLs are often stronger or stiffer than those of some other IOLs, and therefore these silicone-based IOLs are often "springy" by comparison. As a result of this elasticity, a folded silicone-based IOL unfolds very quickly when pushed from the surgical inserter handpiece into the eye during the IOL implantation process. This rapid unfolding of silicone-based IOLs can make it somewhat difficult for surgeons to control and properly align the insertion of the silicone-based IOL during surgery.

[0012] (B1) In contrast, acrylate-based IOLs have softer elastic constants and therefore unfold more slowly during insertion. This feature allows the surgeon greater control over the insertion of acrylate IOLs.

[0013] (L2) Silicone IOL designs are often three-part, with two haptics machined separately and then inserted into the lens body. This design feature increases manufacturing costs and leads to a high rate of haptic misalignment during manufacturing, which can result in the haptics separating from the IOL lens body during insertion.

[0014] (B2) In contrast, some acrylate-based IOLs address these issues by using a one-piece design in which the integral haptics are formed from the same lens material as the central lens body of the IOL in the same molding step. Such one-piece designs are less expensive to manufacture, have better alignment between the haptics and the lens body, and reduce the risk of the haptics separating from the lens body during insertion.

[0015] However, currently known acrylate-based IOLs are not photoaccommodating. These non-photoaccommodating, often acrylate-based, IOLs have their own drawbacks. These drawbacks include:

[0016] (L3) When planning cataract surgery, surgeons first perform a careful and extensive diagnosis of the cataractous eye. Based on this diagnosis, surgeons determine the optimal placement, alignment, and power of the IOL. However, as mentioned above, the IOL often ends up deviating from the planned optimal placement, and in some cases, becoming tilted or misaligned relative to the plan. This can be due to a variety of factors, including variations in the development of ocular tissues after surgery.

[0017] (B3) Photoaccommodating IOLs offer an advanced solution to this problem of misplacement and malalignment. Once the IOL is implanted and adhered to the eye's capsular bag after surgery, a postoperative diagnosis can be performed to identify unintended alignment and misplacement of the implanted IOL. The results of this postoperative diagnosis can be used to determine how to correct the IOL to compensate for the misplacement and malalignment of the implanted IOL. This postoperative determination can be used to perform a photoaccommodation procedure to provide the determined IOL correction for the implanted photoaccommodating IOL.

[0018] (L4) The misalignment problem is particularly acute for toric IOLs, whose implantation goal is to eliminate cylinder in the eye. With toric IOLs, an unintended 10° rotation of the toric IOL's axis after implantation can result in an approximately 30% loss of efficiency. For example, even a 10° rotation of the cylinder axis during or ultimately after implantation can reduce the toric IOL's nominal 3D cylinder or power to an effective 2D cylinder or power.

[0019] (B4) Accommodating IOLs can be implanted without any preformed toric cylinder. After implantation, once the IOL has settled and its unintended rotation has been stopped, the surgeon can use illumination to form a cylinder within the settled IOL and orient its axis precisely in the planned or target direction. Thus, accommodating IOLs avoid the potential loss of efficacy induced by unintentional misalignment of the cylinder axis of a toric IOL.

[0020] This document describes an intraocular lens that combines the advantages (B1)-(B4) of the above two classes of IOLs, and thus potentially overcomes and avoids the disadvantages (L1)-(L4) of each class of IOL itself. Further advantages of various embodiments will become clear below.

[0021] FIG. 1 is a plan view of a composite photoaccommodating intraocular lens 100 including an intraocular lens (IOL) 110, a photoaccommodating lens (LAL) 120 attached to the intraocular lens 110, and haptics 114-1 and 114-2, collectively referred to as haptics 114. The haptics 114 can include various numbers of haptic arms. Embodiments including one, two, three, or four or more haptic arms all have advantages. For the sake of brevity and specificity, the remainder of the description will be in terms of a composite photoaccommodating intraocular lens 100 including two haptic arms 114-1 and 114-2, although it is understood that embodiments including other numbers of haptic arms are within the scope of the overall description.

[0022] 2A-2C and 3 are side views of an embodiment of a hybrid photoaccommodating intraocular lens 100, or CLA IOL 100. FIGS. 2A-2C illustrate a CLA IOL 100 in which a photoaccommodating lens 120 can be attached to the proximal surface of the IOL 110. In this document, the terms "proximal" and "distal" are used in reference to light entering through the pupil of the eye. Proximal refers to a location closer to the pupil. The illustrated embodiments differ in the manner in which haptics 114-1 and 114-2 (again, collectively haptics 114) are attached to components of the CLA IOL 100.

[0023] 2A shows a CLA IOL 100 with haptics 114 attached to the IOL 110. For example, the haptics 114 can be co-molded with the IOL 110, as is the case with many of the acrylic or acrylate IOLs described above. These haptics 114 can be formed from the same acrylic material as the IOL 110 itself and can be molded in the same single step as the IOL 110 itself. As described above, such integral haptics 114 are easy to manufacture, are reliably aligned with the IOL 110, and are less likely to separate from the IOL 110 during insertion.

[0024] 2B shows a CLA IOL 100 with haptics 110 attached to a photoaccommodating lens 120. Finally, FIG. 2C shows a CLA IOL 100 with haptics 114 commonly attached to both the IOL 110 and the photoaccommodating lens 120.

[0025] Figure 3 shows a CLA IOL 100 in which a photoaccommodating lens 120 can be attached to the distal surface of the IOL 110. The order of the photoaccommodating lens 120 and IOL 110 in Figures 2A-2C and the order of the IOL 110 and photoaccommodating lens 120 in Figure 3 each have their own advantages.

[0026] In some embodiments, the IOL 110 can be designed or selected to provide most or all of the intended optical power of the CLA IOL 100. In such embodiments, the photoaccommodating lens 120 can be designed to allow only the corrections and adjustments that the surgeon anticipates may be necessary after the CLA IOL 100 is cemented into the eye with any unintended misalignment. Because the role of the photoaccommodating lens 120 in such embodiments is solely to allow for 1D-2D optical power or cylinder correction, the lens can be much thinner than a non-composite photoaccommodating IOL in which all optical power is generated by a photoaccommodating material. Thus, CLA IOL embodiments that include only a corrective photoaccommodating lens 120 can include a much thinner photoaccommodating lens 120. Therefore, adjustment and lock-in of the photoaccommodating lens 120 in such a CLA IOL 100, as described in connection with FIG. 4, requires less illumination power, thereby enhancing the safety of the overall photoaccommodating procedure.

[0027] The photoaccommodating lens 120 can be designed to provide up to 2D of vision correction, whereas in other embodiments it is only up to 1D. In some embodiments, either the IOL 110 or the photoaccommodating lens 120 can be a meniscus lens.

[0028] In terms of chemical composition, in acrylate embodiments, the IOL 110 can include monomers, macromers, or polymers, any of which can include acrylates, alkyl acrylates, aryl acrylates, substituted aryl acrylates, substituted alkyl acrylates, vinyls, or copolymers combining alkyl acrylates and aryl acrylates. In some IOLs 110, the alkyl acrylates can include methyl acrylate, ethyl acrylate, phenyl acrylate, or polymers and copolymers thereof.

[0029] In some embodiments, the chemical composition of the IOL 110 can include a partial blend of the chemical composition of the photoaccommodating lens 120. Such an IOL 110 can include silicone-based monomers or macromers that form polymers or copolymers with acrylates, alkyl acrylates, aryl acrylates, substituted aryl acrylates, substituted alkyl acrylates, vinyl, or copolymers that combine alkyl acrylates and aryl acrylates.

[0030] In some embodiments, the monomers, macromers, or polymers of the IOL 110 can have functional groups that can include hydroxy, amino, vinyl, mercapto, isocyanate, nitrile, carboxyl, or hydride. The functional groups can be cationic, anionic, or neutral.

[0031] In some embodiments, the light modulating lens 120 may include a first polymer matrix and a refraction-modulating composition dispersed within the first polymer matrix, the refraction-modulating composition capable of stimulus-induced polymerization to modulate the refraction of the light modulating lens 120. The first polymer matrix may include a siloxane-based polymer formed from macromer and monomer building blocks that include alkyl or aryl groups.

[0032] In some embodiments of the hybrid photoaccommodating intraocular lens 100, the first polymer matrix can include a partial blend of at least one of acrylate, alkyl acrylate, aryl acrylate, substituted aryl acrylate, substituted alkyl acrylate, vinyl, and copolymers combining alkyl acrylate and aryl acrylate, which can form at least one of a polymer and a copolymer with the compounds of the first polymer matrix.

[0033] The above-described embodiments in which the IOL 110 includes a partial blend of the materials of the light-accommodating lens 120, and in which the light-accommodating lens 120 includes a partial blend of the materials of the IOL 110, can be configured to increase the mechanical, physical, and chemical robustness of the CLA IOL 100 by increasing the compatibility of the materials of the lenses 110 and 120.

[0034] Embodiments of the photo-adjusting lens 120 may also include a photoinitiator to absorb the refractive-modulating illumination and become activated upon absorption of the illumination to initiate polymerization of the refractive-modulating compound. In some embodiments, the photoinitiator of the photo-adjusting intraocular lens 120 may also include an ultraviolet absorber.

[0035] Embodiments of the light-adjustable lens 120 are described in greater detail in commonly owned U.S. Pat. No. 6,450,642, entitled "Lenses capable of post-fabrication power modification," to J.M. Jethmalani et al., which is hereby incorporated by reference.

[0036] 4 illustrates four steps 101a-101d of a process for using illumination to modify the refractive properties of a light-adjusting lens 120. Very briefly, in step 101a, a light-adjusting lens 120, which includes a matrix having therein a photosensitive macromer formed from a suitable material such as silicone, is illuminated with lens-adjusting light having a radial profile.

[0037] In step 101b, exposure to the modulated light polymerizes the photosensitive macromer, the radial profile of which is determined by the radial profile of the modulated light.

[0038] In step 101c, unpolymerized macromer diffuses into the central region where the photosensitive macromer has already been photopolymerized, causing the central region of the light accommodating lens 120 to expand. (In a complementary process where the radial profile of the illumination light intensifies toward the peripheral annulus of the light accommodating lens 120, the unpolymerized macromer diffuses outward toward the peripheral annulus, causing it to expand.)

[0039] Further, in step 101c, after this expansion, a lock-in light having an essentially uniform radial profile and higher intensity can be applied to polymerize any remaining macromers. In step 101d, this lock-in causes the light-adjustable lens 120 to reach and stabilize its light-adjusted power shape by expanding its center. The above is only a very brief summary of the light-adjustable lens and its light-adjustment procedure. A more detailed description can be found in U.S. Patent No. 6,450,642 to J.M. Jethmalani et al.

[0040] In some embodiments, the IOL 110 and the photoaccommodating lens 120 are adapted to maintain chemical separation after attachment. This chemical separation can be achieved, for example, by employing a refraction-modulating composition in the photoaccommodating lens 120 that is not soluble in the material of the IOL 110, and therefore does not diffuse from the photoaccommodating lens 120 into the IOL 110 despite migration of its component macromers within the first polymer matrix of the photoaccommodating lens 120 itself.

[0041] As noted above, one advantage of combining an IOL 110, which may be acrylic-based, with an accommodating lens 120, which may be silicone-based, is that the elastic constants of the acrylic IOL 110 can be softer than the corresponding elastic constants of the silicone accommodating lens 120. In a CLA IOL 100 in which the IOL 110 is significantly more flexible than the accommodating lens 120, the overall "elasticity" of the CLA IOL 100 can be significantly less than the elasticity of the accommodating lens 120 alone. Such a CLA IOL 100 can be inserted with substantially improved control and predictability during cataract surgery, thereby improving surgical outcomes.

[0042] As described with respect to FIG. 4, in some embodiments, the refractive properties of the photoaccommodating lens 120 are modified by applying ultraviolet (UV) illumination. For safety reasons, the applied UV illumination should be prevented from reaching the retina of the eye, or at least the intensity of its transmitted component should be significantly attenuated. To this end, some embodiments of the CLA IOL 100 can include a UV absorber. There are several different designs for including a UV absorber.

[0043] In some embodiments, a UV absorber may be associated with the light modulating lens 120. Figure 5 shows that in some designs, a UV absorbing layer 130 may be formed on the distal surface of the light modulating lens 120. In other embodiments, the UV absorbing material may be dispersed throughout the light modulating lens 120.

[0044] In another design, a UV absorber can be associated with the IOL 110. Because UV light must reach the photoaccommodating lens 120 for the accommodative procedure, in such an embodiment, the photoaccommodating lens 120 can be attached to the proximal surface of the IOL 110 so that the UV absorber within the IOL 110 does not block UV illumination from reaching the photoaccommodating lens 120. In such an arrangement, in some embodiments, the UV absorbing material can be dispersed throughout the IOL 110, while in other embodiments, the CLA IOL 100 can include a UV absorbing layer 130. Either of these designs is possible because the UV absorbing layer 130 is located distal to the photoaccommodating lens 120, whether on the proximal or distal surface of the IOL 110.

[0045] In embodiments of the hybrid photoaccommodating intraocular lens 100, the photoaccommodating lens 120 can be attached to the IOL 110 by a variety of designs. In some examples, the photoaccommodating lens 120 can be attached to the IOL 110 by a chemical reaction, a heat treatment, an illumination treatment, a polymerization process, a molding step, a curing step, a lathing step, a low-temperature lasing step, a mechanical process, the application of an adhesion promoter, or any combination of these methods.

[0046] 6 shows that some embodiments of the CLA IOL 100 can include a mounting structure 135 for attaching the photoaccommodating lens 120 to the IOL 110. This mounting structure 135 can include, among other things, a cylinder, a ring, a release tab, or a clasp into which an optic can be inserted. Such a structure can have several advantages.

[0047] (a) For example, the CLA IOL 100, including the mounting structure 135, can be modular. This can be advantageous for pre-operative purposes because it allows the surgeon to maintain much less inventory. Once the pre-operative diagnosis determines which IOL 110 needs to be paired with which photoaccommodating lens 120, the surgeon can select the separately stored IOL 110 and the separately stored photoaccommodating lens 120 and assemble the CLA IOL 100 by inserting the two selected lenses into the mounting structure 135.

[0048] (b) This modularity can also be advantageous postoperatively: if, for whatever reason, the choice of IOL 110 is deemed suboptimal at the end of cataract surgery, a non-modular CLA IOL 100 would require the surgeon to reopen the eye and remove the entire implanted CLA IOL 100, including the splayed haptics 114. Removal of such an entire IOL presents considerable challenges and can lead to undesirable medical outcomes, such as breakage of the haptic components.

[0049] In contrast, if a modular CLA·IOL100 had been implanted, the surgeon would not need to remove the entire CLA·IOL100 when the eye was reopened, but would simply remove the suboptimal IOL110 and replace it with a better-selected IOL110. This procedure avoids the need to remove the entire CLA·IOL100, thus reducing the risk of adverse medical outcomes. Another medical benefit is that because only part of the IOL is being replaced, such an exchange procedure typically requires a potentially shorter incision.

[0050] (c) Finally, IOLs including longer structures have advantages in relation to reducing posterior capsule opacification, i.e., PCO, as will be discussed in more detail below in connection with Figures 12A and 12B. The CLA IOL 100, including its attachment structure 135, can be as long as the surgeon desires.

[0051] In embodiments of the CLA IOL 100, the IOL 110 can be an advanced, complex IOL, such as a multifocal IOL, an aspheric IOL, a toric IOL, or a diffractive IOL. Such advanced IOLs provide vision correction in addition to optical power correction. These IOLs help reduce presbyopia, astigmatism, cylinder, or other types of aberrations. However, these advanced IOLs require greater than normal precision in their placement to perform. If the final misplacement or malalignment of the implanted IOL is discovered at the end of or after cataract surgery, the visual improvement and benefit may be significantly inferior to the patient's expected outcome. The fact that such unintended misalignment and rotation occur in a significant percentage of cataract surgeries is a major factor limiting the widespread market acceptance of such advanced IOLs.

[0052] In contrast, the photoaccommodating lens 120 of the CLA·IOL 100 can be adjusted to compensate for misalignment or rotation if the CLA·IOL 100 is misplaced, misaligned, or rotated relative to its intended intraocular position, angle, or orientation. Therefore, the CLA·IOL 100 can reliably provide patients with the expected visual improvement. This advantage of the CLA·IOL 100 may lead to rapid expansion of market acceptance and market share for advanced IOLs.

[0053] In some other embodiments, insertion of the embodiment of Figure 6 may be facilitated by making the attachment structure 135 a fluid-filled structure rather than a rigid structure. Such a fluid-filled attachment structure 135 may be inserted into the eye in an unfilled form and filled with liquid only after insertion. In some embodiments, the distal surface of the light accommodating lens 120 may also be provided with a UV absorbing layer 130.

[0054] 7A-7C, 8A-8C, and 9 illustrate the above general considerations for a CLA IOL 100, including a toric IOL 110, intended to correct the cylinder power of an eye.

[0055] 7A illustrates a planned surgical situation in which the surgeon has decided to implant a CLA IOL 100 including a toric IOL 110 to compensate for the eye's cylinder power, with its target toric axis 202 pointing in a designated direction, chosen for simplicity and clarity to be vertical in the plane of FIG. 7A. Often, the toric IOL includes an axis marker 203 to indicate the orientation of the toric axis to the surgeon.

[0056] Figure 7B shows that after cataract surgery is completed and the incision is closed, the implanted CLA·IOL100 may rotate for various reasons, resulting in the toric axis 204 of the implanted CLA·IOL100 rotating after implantation and forming an unintended rotation angle α with the target toric axis 202.

[0057] Figure 7C shows a state in which the surgeon designs and performs an illumination procedure on the photoaccommodating lens 120 of the CLA IOL 100 to create a counter-rotated toric pattern 206, thereby causing a counter-rotation of the entire toric axis, so that the corrected toric axis 208 after the photoaccommodation procedure points in the same direction as the originally planned target toric axis 202.

[0058] FIG. 8A illustrates the same procedure for the levels of cylinder patterns 212-218. During the preoperative planning phase of cataract surgery, a surgeon may decide to treat a patient's cylinder vision problem by implanting a CLA IOL 100 including a toric IOL 110 with a target cylinder pattern 212 oriented as shown. However, after implantation, the CLA IOL 100 is unintentionally rotated to implanted rotated cylinder 214. Such misaligned and rotated cylinder 214 significantly reduces the visual improvement, as discussed above. As the rotation angle increases, implanted rotated cylinder 214 can become a net negative effect, causing more discomfort and disorientation to the patient than any benefit.

[0059] To compensate for this undesirable medical outcome, the surgeon can perform a post-operative diagnostic procedure to determine and implement a corrective de-rotational cylinder 216 to correct the unintended, undesired rotation of the CLA IOL 100. As shown, the surgeon can perform a photoaccommodating procedure on the photoaccommodating lens 120 of the CLA IOL 100 to form a de-rotational cylinder 216 within the photoaccommodating lens 120. The overlap of the implanted, rotated cylinder 214 and the de-rotational cylinder 216 can result in a photoaccommodating lens shape having a corrected cylinder 218 whose orientation matches the orientation of the originally planned target cylinder 212. These steps are similar to those described above with reference to FIGS. 7A-7C.

[0060] FIG. 8B illustrates the same procedure in geometric terms, representing cylinder patterns with corresponding vectors. The vector direction indicates the direction of the represented cylinder, and the vector magnitude can represent the strength, curvature, or diopter of the cylinder. Target toric vector 222 represents target cylinder 212, and implanted rotated toric vector 224 represents the post-implant rotated cylinder 214 of the implanted CLA IOL 100. As described above, the surgeon can post-operatively determine counter-rotational toric vector 226, which represents the counter-rotated cylinder 216 needed to correct the unintended post-operative rotation of the toric IOL 110. When the surgeon performs a photoaccommodation procedure using counter-rotational toric vector 226 to adjust the photoaccommodating lens, the superposition of implanted rotated toric vector 224 and counter-rotational toric vector 226 restores corrected toric vector 228 to have the same direction and magnitude as target toric vector 222.

[0061] 8C illustrates, in vector representation terms, that there are different ways to achieve the required correction. For example, the correction pattern can include a reductional toric vector 227 that reduces or eliminates the implanted rotated toric vector 224. A counter-rotational toric vector 226 can then be selected to rotate the remainder of vector 224 (equal to the sum of vectors 224 and 227) to result in a corrected toric vector 228.

[0062] In a demonstrative example, in an embodiment of the CLA IOL 100 that includes a toric IOL 110 for correcting more than 2D of cylinder, the photoaccommodating lens 120 can be adapted to correct up to 2D of cylinder. For example, if the toric IOL 110 is intended to correct 6D of cylinder but the toric axis is rotated by only 10 degrees, this will result in a 30% loss of efficiency as described above, resulting in a net cylinder improvement of only 4D for the patient. However, a surgeon can also restore the full expected 6D of cylinder to the patient by performing a photoaccommodating procedure on the photoaccommodating lens 120 to correct the 2D of cylinder lost due to the unintended rotation.

[0063] 9 illustrates in more general terms the steps of a corresponding method 230 for adjusting an implanted compound photoaccommodating intraocular lens 100. The method 230 may include the following steps. 231: Steps for planning the target visual outcome of implanting a hybrid photoaccommodative intraocular lens into an eye. 232: Implanting a composite photoaccommodating intraocular lens into the eye. 233: Performing diagnostic measurements to assess the implant visual outcome of the implant. 234: Determining a correction based on a comparison of the planned visual outcome and the implant visual outcome. 235: A step of applying a stimulus to adjust the optical properties of the combined photoaccommodating intraocular lens to cause the determined correction.

[0064] 7A-7C and 8A-8C, the method 230 can be adapted to cases where the target visual outcome is the target cylinder axis 202 / 212 / 222, the implanted visual outcome is the implanted and rotated cylinder axis 204 / 214 / 224, and the determined correction is the counter-rotated cylinder axis 206 / 216 / 226. These steps can adjust the implanted and rotated cylinder axis 204 / 214 / 224 to a corrected cylinder axis 208 / 218 / 228 that is closely related to the target cylinder axis 202 / 212 / 222.

[0065] 10-11, an embodiment of a CLA IOL 100 is shown that provides the additional medical benefit of reduced chromatic aberration. This embodiment is based on the principle that the optical system of the eye, the primary components of which are the cornea and the lens, reduces the effective refractive index n of the involved ocular tissues. e depends on the wavelength of light, i.e., n e =n e It is developed starting from the observation that chromatic dispersion is exhibited by the fact that n e The derivative of (λ) is typically negative, i.e., ∂n e We know that / ∂λ<0. Therefore, (n e -1) proportional to the refractive power P of the eye e also has a negative derivative with respect to wavelength, i.e., ∂P e / ∂λ<0. Even in a healthy person with 20 / 20 vision, this chromatic dispersion of the eye tissues causes the short-wavelength ("blue") components of the image to be focused closer to the retina, while the long-wavelength ("red") components are focused further away from the retina, resulting in a degree of blurring and reduced image quality. This blurring of the chromatic components of the image is often referred to as chromatic aberration.

[0066] Our brains have learned to accept this chromatic aberration to some extent. Nevertheless, cataract surgery can offer additional medical benefits by implanting a chromatic aberration-correcting IOL, which compensates for the eye's own chromatic aberration and focuses all wavelength components onto the retina, thereby reducing chromatic aberration and sharpening vision.

[0067] The wavelength dependence of the refractive index is often characterized by the Abbe number, defined as V = (nD-1) / (nF-nC), where nD, nF, and nC are the refractive indices at the Fraunhofer D, F, and C spectral lines at 589, 486, and 656 nm, respectively. Most Abbe numbers are in the range of 20 to 90. For corneal and lens tissue, the Abbe number is in the range of 50 to 60. The refractive power P of an intraocular lens is l is the lens manufacturer's equation P l =(n l -1)(1 / R l -1 / R2) through the refractive index n l (λ), where R l and R2 are the radii of curvature of the two surfaces of the intraocular lens. Therefore, n l The λ dependence of the intraocular lens power P l is also made dependent on the wavelength λ, i.e., P l =P l (λ). This dependence also depends on the sign of the lens power. For a positive power lens, it is usually negative ∂n l / ∂λ<0 is negative ∂P l / ∂λ<0, whereas negative power leads to negative ∂n l / ∂λ<0 is positive ∂P l yields / ∂λ>0.

[0068] With these as a preamble, the intraocular lens compensates for the negative wavelength derivative of the eye's refractive power by ∂P l / ∂λ+∂P e Chromatic aberration can be compensated for when ∂λ≒0. l / ∂λ≒-∂P e / ∂λ>0.

[0069] By the way, a normal (non-diffractive) intraocular lens has a positive refractive power of about 20D. l Therefore, in light of the introduction, these ∂P l / ∂λ is negative and ∂P e Since / ∂λ is also negative, it cannot compensate for the eye's own chromatic aberration.

[0070] However, embodiments of the CLA IOL 100 are formed by two different lenses: the IOL 110 and the photoaccommodating lens 120. Such a two-lens design opens up genuinely new possibilities. One of the lenses of the CLA IOL 100 can have a negative refractive power, and thus a strongly positive ∂P / ∂λ>0, so that the combined two-lens CLA IOL 100 can compensate for chromatic aberrations in the eye's optical system, while the combined refractive power of the two lenses can still perform the primary function of an intraocular lens and provide approximately 20D. In the formula, the refractive power P of the first lens of the two-lens CLA IOL 100 is l,1 and the refractive power P of the second lens l,2 However, the following two relationships can be satisfied simultaneously: P l,1 +P l,2 =20D (1) ∂P l,1 / ∂λ+∂P l,2 / ∂λ≒-∂P e / ∂λ>0 (2)

[0071] In some detail, FIGS. 10A and 10B illustrate an embodiment of a CLA IOL 100 that provides such reduced chromatic aberration. Conventionally, in such complex lenses, the negative power lens is often referred to as the "flint" and the positive power lens as the "crown." If the complex lens itself exhibits near-zero chromatic aberration, the CLA IOL 100 can be referred to as an "achromat." If the complex lens forms a larger complex, such as the CLA IOL 100 plus an eye, that exhibits near-zero chromatic aberration, the CLA IOL 100 can be referred to as an "achromator."

[0072] FIG. 10A shows a negative refractive power P IOL <0 is a flint and has a positive refractive power P LAL 10B shows an embodiment in which the light accommodating lens (LAL) 120 is a crown having a positive refractive power P IOL>0, and the photoaccommodating lens 120 has a negative refractive power P LAL Illustrates the opposite embodiment with .times. ...

[0073] The magnitude of ∂n / ∂λ, |∂n / ∂λ|, is relatively high for PMMA and generally low for silicone. Therefore, an embodiment of a CLA IOL 100, including the design of FIG. 10A, in which the negative power IOL 110 is formed from PMMA or other acrylates or similar and the positive power photoaccommodating lens 120 is formed from silicone, can effectively reduce chromatic aberration. In this embodiment, a PMMA IOL 110 with a high |∂n / ∂λ| has P IOL Silicone LAL120, which can provide low negative refractive powers such as -10D and has a low |∂n / ∂λ|, has LAL Therefore, the combined refractive power of the CLA·IOL100 is as follows: P IOL +P LAL ≒+20D (3)

[0074] Meanwhile, at the same time, the CLA·IOL 100 can also compensate for the chromatic aberration of the eye as follows. ∂P IOL / ∂λ+∂P LAL / ∂λ≒-∂P e / ∂λ (4)

[0075] Such a CLA·IOL100 provides an overall refractive power of approximately 20D, while the combined wavelength derivative of the refractive powers of the IOL110 and LAL120 significantly compensates for the chromatic aberration of the optics of the eye, thereby substantially reducing the overall chromatic aberration of the eye after implantation of the CLA·IOL100. (Here, "optics of the eye" refers primarily to the cornea, since the crystalline lens has been removed by cataract surgery.)

[0076] Figure 11 illustrates the above concept in terms of color shift. Color shift characterizes the distance of the image from the target / imaging plane (or from the retina in the case of the eye) and is measured in diopters. A negative color shift indicates that the image is formed closer, in front of the retina, whereas a positive color shift indicates that the image is formed further behind the retina. Therefore, a color shift that increases with wavelength indicates that refractive power decreases with wavelength, i.e., ∂P / ∂λ<0.

[0077] Figure 11 shows that the natural eye's optical system alone is ∂P e The results show that the color shift increases with ∂P IOL The chromatic shift increases, consistent with / ∂λ<0. The dashed "combined photoaccommodating IOL" line indicates that when a chromatic aberration-compensating embodiment of the CLA·IOL100 is implanted in the eye, the combined CLA·IOL100 and eye system exhibits minimal chromatic shift and chromatic aberration.

[0078] Thus, in embodiments of the CLA IOL 100, the IOL 110 has an IOL color shift variation, the photoaccommodating lens 120 has a photoaccommodating lens color shift variation, and the crystalline lens-removed eye has an ocular color shift variation, and the color shift variation of an eye implanted with the composite photoaccommodating intraocular lens 100 can be less than the color shift variation of an eye with a crystalline lens in place, where the color shift variation is defined as the difference in color shift at 450 nm and 650 nm.

[0079] In embodiments of the CLA IOL 100, the optical power of the IOL 110 can be negative and the optical power of the photoaccommodating lens 120 can be positive, resulting in a chromatic shift variation of less than 0.5D in an eye implanted with the combined photoaccommodating intraocular lens. In other embodiments, this chromatic shift variation can be less than 0.2D. An obvious additional medical benefit of an eye implanted with such an achromatic CLA IOL 100 is that the blurring of images due to chromatic dispersion can be substantially less than that of a natural eye, thereby providing additional visual clarity.

[0080] A technical concept for achromatic IOLs, including related aspects, has been proposed in E.J. Fernandez and P. Artal, "Achromatic doublet intraocular lens for full aberration correction," Biomedical Optics Express, Vol. 8 (2017), p. 2396, which is incorporated herein by reference. While useful in some respects, this paper does not specifically address the accommodative function of related IOLs. Further technical concepts are needed to adapt this technology to accommodative lenses.

[0081] 12A and 12B illustrate a further medical advantage of the CLA IOL 100, particularly where the IOL 110 or accommodating lens 120 has negative optical power and therefore has very long sides 142 and sharp IOL edges 144. In such embodiments, the sharp IOL edges 144 can be pressed against the capsular bag 15 of the inserted eye with a greater force than would be exerted on a single component intraocular lens.

[0082] This increased force can provide the following notable medical benefits: Posterior capsule opacification (PCO) is one of the well-known negative outcomes or complications of cataract surgery. PCO is caused by the growth and abnormal proliferation of lens epithelial cells (LECs) in the posterior capsule. Most PCOs are fibrous or pearly, or a combination of these. PCOs can be detected clinically, for example, as wrinkles in the posterior capsule. The development of PCO is often accompanied by three basic phenomena: proliferation, migration, and differentiation of residual LECs.

[0083] Although various medications have been developed to reduce PCO, it has been shown that PCO can also be reduced by the formation of a sharp mechanical barrier in contact with the lens capsule 15. Such a barrier reduces PCO by inhibiting fiber growth and reducing LEC movement.

[0084] In the CLA·IOL100 embodiment, the achromatic flint lens has negative refractive power and therefore has very long sides 142 that are longer than the center, causing the sharp IOL edge 144 to press with great force against the capsular bag 15. Therefore, the achromatic embodiment of the CLA·IOL100 exhibits the additional medical benefit of reducing PCO.

[0085] 12A and 12B illustrate that there are multiple possible combinations and designs of CLA IOLs 100 that compress the capsular bag 15 with greater than normal force. For example, the order of the IOL 110 and the accommodating lens 120 can be reversed. In other embodiments, the flint and crown materials can be swapped. A CLA IOL 100 with a distal crown lens, i.e., a crown lens closer to the retina, can advantageously exhibit lower aberrations because the shape of its most distal surface is closest to the shape of the retina. In contrast, if the flint is closer to the retina, the most distal surface will be substantially different from the retinal surface and therefore will produce higher aberrations.

[0086] Yet another medical advantage of these CLA IOLs 100 that include longer sides is that the higher compressive forces induce higher capsular tension, which tends to stabilize the placement and axis of the CLA IOL 100 better than the lower capsular tension induced by a flat, standard IOL, thereby preventing the CLA IOL 100 from tilting or otherwise becoming misaligned.

[0087] The long IOL lateral surface 142 may require the creation of a large or long surgical incision, which may further induce unintended astigmatism after cataract surgery. However, in embodiments of the CLA IOL 100, the ability to adjust the photoaccommodating lens 120 after surgery allows this astigmatism to be effectively compensated for and eliminated by applying an astigmatism-compensating photoaccommodation procedure to the photoaccommodating lens 120.

[0088] 13 illustrates one embodiment of a hybrid photoaccommodating intraocular lens 100, including an acrylic intraocular insert 110′, a silicone-based (silicone-based) photoaccommodating lens 120 attached to the acrylic intraocular insert 110′ by an adhesion promoter 300, and haptics 114-1 and 114-2. In embodiments, the adhesion promoter 300 may include a first orthogonal functional group configured to bond with the acrylic component of the acrylic intraocular insert 110′ and a second orthogonal functional group configured to bond with the silicone component of the silicone-based photoaccommodating lens 120, as described in more detail below. For brevity, the silicone-based photoaccommodating lens 120 may be abbreviated as a light adjustable lens 120, or LAL 120, in parts of the description and in the drawings.

[0089] The acrylic intraocular insert 110' may include an intraocular lens (IOL) 110 with refractive power, and the acrylic intraocular insert may be considered an embodiment of the IOL 110. In some cases, the acrylic intraocular insert 110' may include a carrier with near zero refractive power, and conversely, the intraocular lens (IOL) 110 may be considered an embodiment of the acrylic intraocular insert 110' with or without refractive power.

[0090] These embodiments include an adhesion promoter 300 to ensure that the two main components of the hybrid photoaccommodating IOL 100, namely the acrylic intraocular insert 110' and the silicone-based photoaccommodating lens 120, are chemically bonded to one another and do not delaminate after the implantation and photoaccommodating procedure.

[0091] Acrylic IOLs attached by chemical means around the rim of a silicone frame or to silicone biasing elements for presbyopic applications have been described above, however, there are at least the following differences between those IOLs and the presently described CLA IOL 100:

[0092] (1) The optic or viewing element in the IOL has a fixed, unchanging shape. Therefore, strain and tension at the acrylic-silicone junction can be minimized by a proper fabrication process. Furthermore, IOLs with substandard junctions can be discarded during the fabrication process as part of quality control. This contrasts with CLA IOL 100 embodiments, detailed in FIGS. 14A-14C, in which the photoaccommodating procedure changes the shape of the silicone-based photoaccommodating lens 120 after implantation while leaving the shape of the acrylic intraocular insert 100' essentially unchanged. In these CLA IOLs 100, the photoaccommodating procedure induces shear and stress at the silicone-acrylic junction after implantation, potentially even causing the two elements to delaminate from each other. Because the magnitude of accommodation varies from patient to patient, photoinduced stress and tension cannot be minimized by a proper fabrication process prior to implantation. Instead, the silicone-acrylic bond must be stress-resistant, withstanding light-induced tension to the necessary degree, including withstanding the tendency of the silicone-based photoaccommodating lens 120 to delaminate from the acrylic intraocular insert 110' as a result of photoaccommodation. This is a particularly demanding expectation, since an implanted CLA IOL 100 with delaminated components cannot be discarded.

[0093] (2) For most of the IOLs described above, silicone forms the frame or biasing elements or is positioned around the edge of the acrylic IOL. In such IOLs, the silicone-acrylate interface is not in the optical path, and therefore the requirement for a silicone-acrylic junction is less significant to avoid compromising image quality. In contrast, in embodiments of the CLA IOL100, the silicone-acrylic interface is in the optical path; thus, the entire interface is expected to transmit light without distortion, despite photoaccommodation procedures that induce tension and strain at the silicone-acrylic interface. The two considerations described above represent a significant difference between conventional designs and embodiments of the CLA IOL100.

[0094] 14A-14C illustrate point (1) above regarding the difference between the currently described CLA IOL 100 and conventional systems, highlighted by the accommodative properties of the silicone LAL 120. FIG. 14A illustrates the application of refractively modulated illumination to the CLA IOL 100. FIG. 14B illustrates the silicone LAL 120 of the CLA IOL 100 changing its shape in response to this illumination. The illustrated case illustrates an accommodative strategy that increases the optical power of the silicone LAL 120, in which the radius of curvature of the anterior surface decreases, while the radius of curvature of the posterior surface often increases. An accommodative strategy that decreases optical power induces the opposite change in curvature. FIG. 14C is an enlarged view of a portion of the interface between the acrylic intraocular insert 110′ and the silicone LAL 120. Refractively modulated illumination induces curvature changes and lateral shearing 111 in the silicone-based LAL 120, causing the silicone-based LAL 120 to delaminate from the acrylic intraocular insert 110′, potentially inducing separation 112. Thus, in contrast to IOLs with fixed geometric elements, refractively modulated illumination inevitably induces tension and strain at the interface between the acrylic intraocular insert 110′ and the silicone-based LAL 120. This strain and tension is induced only after the fabrication process and after implantation, and thus cannot be eliminated by fabrication modifications. Thus, the CLA IOL 100 requires an adhesion promoter 300 that chemically bonds the two surfaces with sufficient strength to prevent separation between the acrylic intraocular insert 110′ and the silicone-based LAL 120 despite the tension and strain induced by the shape changes caused by refractively modulated illumination.

[0095] As before, Figures 15A and 15B show that in some embodiments of the composite light adjustable intraocular lens 100, or CLA IOL 100, the haptics 114-1, 114-2 can be attached to the acrylic intraocular insert 110', in other embodiments the haptics 114-1 / 114-2 may be part of the acrylic intraocular insert 110', in still other embodiments the haptics 114-1 / 114-2 can be attached to the silicone-based light adjustable lens 120, and finally, in some CLA IOLs 100, the haptics 114-1 / 114-2 can be attached to both the acrylic intraocular insert 110' and the silicone-based light adjustable lens 120.

[0096] 13-17 show embodiments of the CLA IOL 100 in which a silicone-based photoaccommodating lens 120 is attached proximally to an acrylic intraocular insert 110', ie, positioned closer to the cornea of ​​the eye.

[0097] Just like the IOL 110, embodiments of the acrylic intraocular insert 110' may comprise at least one of a monomer, macromer, oligomer, and polymer selected from the group consisting of acrylate, alkyl acrylate, aryl acrylate, substituted aryl acrylate, substituted alkyl acrylate, halogen-substituted acrylate, halogen-substituted methacrylate, acrylic ester, or acrylic acid, acrylamide, vinyl, and copolymers of alkyl acrylate and aryl acrylate. For some CLA IOLs 100, the monomer may be methyl acrylate, ethyl acrylate, ethylhexyl acrylate, phenyl acrylate, ethyl methacrylate, trifluoroethyl acrylate, trifluoroethyl methacrylate, n-butyl acrylate, hydroxyethyl acrylate, hydroxymethyl acrylate, n-vinylpyrrolidone, phenoxyethyl acrylate, or a polymer or copolymer thereof.

[0098] Additionally, a corresponding bis- or multifunctional crosslinker may be present to aid polymerization. For some CLA·IOL100s, the crosslinker may be ethylene glycol dimethacrylate, tetraethylene glycol dimethacrylate, propylene glycol dimethacrylate, and propylene glycol diethacrylate. Furthermore, the crosslinked network may be induced by a thermal, UV-initiated, or catalytically accelerated reaction. For some CLA·IOL100s, the thermal initiator may be 2,2-azobis(2,4-dimethylpentanitrile), 2,2-azobis(2,4-dimethylbutanenitrile), azobisisobutyronitrile, azobisisopropionitrile, or azobisisomethylpropionitrile. For some CLA·IOL100s, the photoinitiator may be benzophenone, benzoin alkyl ether, benzil ketal, phosphine oxide, acyl oxime ester, acetophenone, or an acetophenone derivative.

[0099] 4, the silicone-based light regulating lens 120 may comprise a first polymer matrix and a refractive index-modulating composition dispersed within the first polymer matrix, the refractive index-modulating composition capable of stimulus-induced polymerization to modulate the refractive index of the silicone-based light regulating lens 120. The first polymer matrix may include a siloxane-based polymer formed from macromer and monomer building blocks with at least one of alkyl and aryl groups.

[0100] Additionally, the CLA·IOL 100 may include a photoinitiator configured to be activated upon absorption of refractive-modulating illumination and to initiate stimulus-induced polymerization of the refractive-modulating composition. To provide protection and safety, the CLA·IOL 100 may include an ultraviolet absorber.

[0101] 16A and 16B illustrate various ways in which the adhesion promoter 300 can be incorporated into the CLA IOL 100. FIG. 16A illustrates that in some CLA IOLs 100, the adhesion promoter 300 can be dispersed within the acrylic intraocular insert 110′. FIG. 16B illustrates that in some CLA IOLs 100, the adhesion promoter 300 can be dispersed within the adhesive layer 310 between the acrylic intraocular insert 110′ and the silicone-based photoaccommodating lens 120. Finally, in some CLA IOLs 100, the adhesion promoter 300 can be dispersed within the silicone-based photoaccommodating lens 120. In some embodiments, the adhesion promoter 300 can be dispersed within some combination of the embodiments of FIGS. 17A-17C.

[0102] Figures 17A-17C show these same embodiments with somewhat different incorporation. Figure 17A shows the embodiment of Figure 16A in which the adhesion promoter 300 is primarily dispersed within the acrylic intraocular insert 110' and is bonded to the silicone-based LAL 120 by silicon-carbon covalent bonds 320 and to the acrylate of the acrylic intraocular insert 110' by bonds 322. The circled portion is a schematic representation of a first orthogonal functional group configured to bond with the acrylic component of the acrylic intraocular insert 110' by bonds 322. The triangle is a schematic representation of a second orthogonal functional group configured to bond with the silicone component of the silicone-based photoaccommodating lens 120 by covalent bonds 320. Both orthogonal functional groups, depicted schematically as circles and triangles, are selected to uniquely bond with their complementary counterparts. Figure 17B illustrates the embodiment of Figure 16B in which the adhesion promoter 300 is primarily dispersed within the adhesive layer 310, which is bonded to the silicone-based LAL 120 by covalent chemical bonds 320 and to the acrylate of the acrylic intraocular insert 110' by bonds 322. Figure 17C illustrates an embodiment in which the adhesion promoter 300 is primarily dispersed within the silicone-based LAL 120, which is bonded to the silicone-based LAL 120 by covalent chemical bonds 320 and to the acrylate of the acrylic intraocular insert 110' by bonds 322.

[0103] Embodiments of the adhesion promoter 300 will now be described in detail. As noted above, the adhesion promoter 300 may include two orthogonal functional groups that can independently participate in polymerization using their unique chemistry, with the first orthogonal functional group configured to bond with the acrylic component of the acrylic intraocular inserter 110′ and the second orthogonal functional group configured to bond with the silicone component of the silicone-based photoaccommodating lens 120. In some embodiments of the CLA IOL 100, the adhesion promoter 300 has the following structural formula (1): JPEG0007799617000001.jpg43150, wherein at least one of R3, R3', and R3" has the following structure (2): JPEG0007799617000002.jpg43150, the remainder of R3, R3', and R3" are independently selected from the group consisting of C1-C10 pendant alkyl groups, e.g., methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl; The first orthogonal functional group is the functional group introduced to the left of R2, the second orthogonal functional group is R6; R1 is selected from the group consisting of hydrogen, a monovalent hydrocarbon group, and a substituted C1-C12 alkyl, wherein alkyl may be methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl; R2 is an alkyl spacer containing 1-10 carbon atoms, (—CH2)n, where n=1-10; R4 and R5 are independently selected from the group consisting of C1-C10 pendant alkyl groups, e.g., methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl; R6 is one of a vinyl group, a vinyloxy group, an aryl group, an aryloxy group, and a group containing a carbon chain C1-C10.

[0104] In some embodiments of CLA·IOL100, R1 is methyl, R2 is propyl, R3, R3′, and R3″ are each vinyldialkylsiloxy, R4 and R5 are each a C1-C10 alkyl chain, and R6 is vinyl.

[0105] In some embodiments, R2 can be a chain, while in other embodiments, R2 can be an alkyl spacer, such as a branched or cyclic isomer of cyclopentyl. Additionally, R2 can be a substituted vinylaryl. Optionally, R2 can further comprise a substituted aromatic group, such as a substituted phenyl or substituted naphthyl.

[0106] The first orthogonal functional group introduced to the left of R2 forms a covalent bond 322 with the acrylic intraocular insert 110'. The second orthogonal functional group is R6, whose double bond interacts with the silicon hydrate to form a new covalent silicon-carbon bond 320, thereby forming a covalent bond 320 with the silicone-based LAL 120.

[0107] Adhesion promoter 300 with more double bonds will result in more covalent bonds 320 with the silicone-based LAL120. Increasing the number of available double bonds is possible by selecting two or all three of R3, R3', and R3", including R6, each of which has a double bond, to be vinyldialkylsiloxy pendant groups. The resulting adhesion promoter 300 is shown in structural formula (3) below. JPEG0007799617000003.jpg74160

[0108] This embodiment of the adhesion promoter 300 is called methacryloxypropyltris(vinyldimethylsiloxy)silane, which has the structural formula (3), where R1 is methyl, R2 is propyl, R3, R3′, and R3″ are vinyldimethylsiloxy, R4 and R5 are methyl, and R6 is vinyl. This structural formula (3) is a suitable adhesion promoter 300 because it contains three vinyl R6 groups, each with a double bond, and thus can bond to the silicone-based LAL 120 with doubled strength, which, as discussed above, holds promise for preventing delamination between the acrylic intraocular insert 110′ and the silicone-based LAL 120 and optical distortion at their interface.

[0109] The overall bond strength between the acrylic intraocular insert 110' and the silicone-based LAL 120 provided by the adhesion promoter 300 depends on the strength and number of covalent bonds 320 per individual adhesion promoter molecule and the concentration of these molecules. It was found that concentrations of methacryloxypropyltris(vinyldimethylsiloxy)silane as the adhesion promoter 300 dispersed within the acrylic intraocular insert 110' greater than 5% by weight were sufficient to (1) prevent delamination between the acrylic intraocular insert 110' and the silicone-based LAL 120, even after refractively modulated illumination, and (2) avoid optical distortion at the acrylic intraocular insert 110'-silicone-based LAL 120 interface. CLA·IOL 100 with concentrations greater than 10% by weight performed particularly well. For adhesion promoter 300 having structural formula (1), but where only one of the R groups is a vinyldialkylsiloxy pendant group, concentrations greater than 10% by weight were found to provide a bond of sufficient quality.

[0110] Structural formula (3) can be viewed as a monomer unit within the formulation of the acrylic intraocular insert 110', where structural formula (3) can act as the adhesion promoter 300. In related embodiments, the corresponding building blocks include, to name a few: 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)dimethylsilane, acryloxybutyl(vinyldimethylsiloxy)dimethylsilane, styrylmethyltris(vinyldimethylsiloxy)silane, styrylethyltris(vinyldimethylsiloxy)silane, styrylmethyltrisdi(vinyldimethylsiloxy)silane, styrylethyldi(vinyldimethylsiloxy)methylsilane, styrylethyl(vinyldimethylsiloxy)dimethylsilane, and It may be styrylethyl(vinyldimethylsiloxy)dimethylsilane.

[0111] This unit may be attached to the silicone-based LAL120 by a covalent bond 320 between one or more silicon atoms of the silicone-based LAL120 and one or more carbon atoms of the adhesion promoter 300, typically via its R6 group.

[0112] In some CLA·IOLs 100, the covalent bond is created by a hydrosilylation reaction between the vinyl group of the vinyldialkylsiloxy group and the Si—H group of the silicone-based photoaccommodating lens 120. Adhesion promoters 300 with more branches (n>1) have more doubly bonded second orthogonal functional groups and can thus provide stronger bonds to the silicone-based photoaccommodating lens 120, as noted above in connection with structural formula (3).

[0113] 18A and 18B illustrate that in some CLA IOLs 100, the silicone accommodating lens 120 is bonded to the acrylic intraocular insert 110′ at the proximal surface of the acrylic intraocular insert 110′. In these CLA IOLs 100, the acrylic intraocular insert 110′ may include an ultraviolet absorbing material or ultraviolet (UV) absorbing layer 340 dispersed throughout the acrylic intraocular insert 110′. This UV absorbing layer 340 may be located at the proximal surface of the acrylic intraocular insert 110′, as shown in FIG. 18A, or at the distal surface of the acrylic intraocular insert 110′, as shown in FIG. 18B. The CLA IOL 100 of FIG. 18A may be equally characterized as having the UV absorbing layer 340 formed at the distal surface of the silicone accommodating lens 120. All of these embodiments help further enhance the retinal safety of refractive modulation illumination.

[0114] In the CLA IOL 100, the silicone-based photoaccommodating lens 120 may be attached to the acrylic intraocular insert 110' by at least one of a chemical reaction, a heat treatment, an illumination treatment, a polymerization process, a molding step, a curing step, a lasing step, a low-temperature lasing step, a mechanical process, the application of an adhesion promoter, and combinations thereof.

[0115] 19A and 19B show that the acrylic intraocular insert 110' having optical power can have a diffractive structure 350 to provide that optical power, as described above. The diffractive structure 350 can be located on the distal surface of the acrylic intraocular insert 110', as shown. In other cases, the diffractive structure 350 can be located on the proximal surface of the acrylic intraocular insert 110' facing the silicone-based LAL 120. This latter design reduces the halos and glare that are typical of diffractive IOLs.

[0116] In some embodiments of the hybrid photoaccommodating IOL 100, the acrylic intraocular insert 110' can be a toric acrylic intraocular insert 110', which in some embodiments can have optical power.

[0117] We conclude by noting several additional advantages of the hybrid photoaccommodating IOL 100. (1) The hybrid photoaccommodating IOL 100 allows for a reduced volume of photopolymerized material compared to a silicone-only LAL because the acrylic IOL 110 or acrylic intraocular insert 110' can provide a baseline refractive power of 10D, 15D, or 20D. Thus, the silicone-based LAL 120 can be a very thin layer used only to effect a power change relative to the baseline refractive power of the acrylic IOL 110 / insert 110'. The smaller volume of photopolymerized material corresponds to a lower intensity and radiance of the refractively modulated illumination, thereby making the procedure safer.

[0118] (2) In some cases, refractively modulated illumination has competing effects on the two surfaces of the silicone-based LAL 120. As shown in FIG. 14B, in some cases, the radius of curvature of the proximal surface of the silicone-based LAL 120 can be reduced, thereby increasing its optical power. However, the same illumination can increase the radius of curvature of the distal surface, thereby decreasing the optical power of the silicone-based LAL 120. These two effects compete with each other, thus slightly reducing the efficiency of refractively modulated illumination. Embodiments of the CLA IOL 100 attach the distal surface of the silicone-based LAL 120 to the IOL 110 or acrylic intraocular insert 110′. This attachment increases the stiffness and resistance of the distal surface of the silicone-based LAL 120 to changes in curvature, thereby reducing the competition for increased optical power induced by the proximal surface of the silicone-based LAL 120. Reducing the curvature change of the distal surface is one of the beneficial effects of the CLA·IOL100, as it reduces the illumination radiance required to achieve the planned power change, thereby further enhancing retinal safety.

[0119] While this patent document describes many particulars, details, and ranges, these should not be construed as limiting the scope of the present disclosure and the invention as set forth in the claims, but rather as descriptions of features specific to particular embodiments of the invention. Certain features described in this patent document in the context of separate embodiments can also be embodied in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be embodied in multiple embodiments separately or in any suitable subcombination. Furthermore, while features may be described above as working in a particular combination and may even be claimed per se, one or more features from a claimed combination can in some cases be omitted from the combination, and the claimed combination may relate to other subcombinations or variations of subcombinations.

Claims

1. A composite photoaccommodating intraocular lens, comprising: an acrylic intraocular insert including a carrier with a ring; a silicone-based photoaccommodating lens inserted into the carrier and its ring of the acrylic intraocular insert with an adhesion promoter; haptics, The adhesion promoter is a first orthogonal functional group configured to bond with an acrylic component of the acrylic intraocular insert; and A hybrid photoaccommodating intraocular lens comprising a second orthogonal functional group configured to bond with a silicone component of the silicone-based photoaccommodating lens.

2. the haptics are attached to the acrylic intraocular insert; and The hybrid photoaccommodating intraocular lens of claim 1 , wherein the haptics have at least one feature that is part of the acrylic intraocular insert.

3. The compound photoaccommodating intraocular lens of claim 1 , wherein the carrier has near zero refractive power.

4. The composite photoaccommodating intraocular lens of claim 1 , wherein the silicone-based photoaccommodating lens is attached proximally to the acrylic intraocular insert.

5. The acrylic intraocular insert comprises:

10. The composite photoaccommodating intraocular lens of claim 1, comprising at least one of monomers, macromers, oligomers, and polymers selected from the group consisting of acrylates, alkyl acrylates, aryl acrylates, substituted alkyl acrylates, substituted aryl acrylates, halogen-substituted acrylates or methacrylates, halogen-substituted aryl acrylates or methacrylates, acrylic esters, acrylic acid, vinyl, and copolymers of alkyl acrylates and aryl acrylates.

6. The monomer is 6. The composite photoaccommodating intraocular lens of claim 5, wherein the compound is selected from the group consisting of methyl acrylate, ethyl acrylate, ethylhexyl acrylate, phenyl acrylate, ethyl methacrylate, trifluoroethyl acrylate, trifluoroethyl methacrylate, n-butyl acrylate, hydroxyethyl acrylate, hydroxymethyl acrylate, n-vinylpyrrolidone, phenoxyethyl acrylate, or polymers or copolymers thereof.

7. The silicone-based photoaccommodating lens comprises: a first polymer matrix, and a refraction-modulating composition dispersed in the first polymer matrix; The hybrid photoaccommodating intraocular lens of claim 1 , wherein the refractive index-modulating composition is capable of stimulus-induced polymerization to modulate the refractive index of the photoaccommodating lens.

8. The first polymer matrix comprises:

8. The composite photoaccommodating intraocular lens of claim 7, comprising a siloxane-based polymer formed from macromeric and monomeric building blocks containing at least one of alkyl and aryl groups.

9. The light-adjustable lens comprises: Refraction-modulated light is activated upon absorption, and a photoinitiator configured to initiate the stimulus-induced polymerization of the refraction-modulating composition; and The composite photoaccommodating intraocular lens of claim 7, further comprising an ultraviolet absorber.

10. The composite photoaccommodating intraocular lens of claim 1 , wherein the adhesion promoter is dispersed within the acrylic intraocular insert.

11. The hybrid photoaccommodating intraocular lens of claim 1 , wherein the adhesion promoter is dispersed within an adhesive layer between the acrylic intraocular insert and the photoaccommodating lens.

12. The hybrid photoaccommodating intraocular lens of claim 1 , wherein the adhesion promoter is dispersed throughout the photoaccommodating lens.

13. The adhesion promoter has the following structural formula: where R 3 , R 3 ' and R 3 " at least one of which has the following structural formula: is a vinyldialkylsiloxy pendant group having the formula R 3 , R 3 ' and R 3 " are independently selected from the group consisting of methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl, which are representative examples of C1-C10 pendant alkyl groups; The first orthogonal functional group is R 2 is a functional group introduced to the left of The second orthogonal functional group is R 6 and R 1 represents hydrogen, a monovalent hydrocarbon group, i.e., and substituted C1-C12 alkyl, wherein said alkyl may be methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl; R 2 is a group of 1-10 carbon atoms, (-CH 2 ) n (where n=1 to 10), R 4 and R 5 is independently selected from the group consisting of methyl, ethyl, n-propyl, isopropyl, cyclopropyl, n-butyl, sec-butyl, t-butyl, cyclobutyl, or methylcyclopropyl, which are representative examples of C1-C10 pendant alkyl groups; R 6 The composite photoaccommodating intraocular lens of claim 1 , wherein is one of a vinyl group, a vinyloxy group, an aryl group, an aryloxy group, and a group containing a carbon chain C1-C10.

14. R 1 is methyl, and R 2 is propyl, and R 3 , R 3 ' and R 3 " are each vinyldialkylsiloxy, and R 4 and R 5 are each a C1-C10 alkyl chain, and R 6 The composite photoaccommodating intraocular lens of claim 13, wherein is vinyl.

15. The adhesion promoter has the following structural formula:

14. The hybrid photoaccommodating intraocular lens of claim 13, comprising methacryloxypropyltris(vinyldimethylsiloxy)silane having the formula:

16. 14. The hybrid photoaccommodating intraocular lens of claim 13, wherein the adhesion promoter is dispersed in the acrylic intraocular insert at a concentration greater than 5% by weight.

17. The hybrid photoaccommodating intraocular lens of claim 13, wherein a silicon-carbon covalent bond is created by a hydrosilylation reaction between the vinyldialkylsiloxy pendant group attached to at least one of the pendant groups and a Si—H group of the silicone-based photoaccommodating intraocular lens.

18. The hybrid photoaccommodating intraocular lens of claim 1 , wherein the photoaccommodating lens comprises an ultraviolet absorbing layer located at a distal surface of the photoaccommodating lens.

19. the photoaccommodating lens is attached to the acrylic intraocular insert at a proximal surface of the acrylic intraocular insert; The acrylic intraocular insert comprises: an ultraviolet absorbing material dispersed throughout the acrylic intraocular insert; and The hybrid photoaccommodating intraocular lens of claim 1 , including at least one ultraviolet absorbing layer formed on at least one of a proximal surface and a distal surface of the acrylic intraocular insert.

20. 10. The composite photoaccommodating intraocular lens of claim 1, wherein the photoaccommodating lens is attached to the acrylic intraocular insert by at least one of a chemical reaction, a heat treatment, an illumination treatment, a polymerization process, a molding step, a curing step, a lathing step, a low temperature lasing step, a mechanical process, application of an adhesion promoter, and combinations thereof.

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