Phakic lenses

Abstract

Provided herein are implantable ocular lenses or phakic lenses designed to be seated on the human crystalline lens. The lenses have a plurality of loops laterally extending from the non-optical periphery of the lens body for securement within the eye and a plurality of rounded knobs perpendicularly, downwardly extending from the non-optical part of the lens for seating the lens. Alternatively, the rounded knots are formed as a continuous modulation of the posterior surface of the phakic lens.

Description

[0001] PHAKIC LENSES

[0002] Cross-Reference to Related Applications

[0003] This international application claims benefit of priority under 35 U.S.C. §119(e) of provisional application U.S. Serial No. 63 / 713,820, filed October 30, 2024, the entirety of which is hereby incorporated by reference.

[0004] BACKGROUND OF THE INVENTION

[0005] Field of the Invention

[0006] The present invention relates generally to the fields of ophthalmology and implantable intraocular lenses (IOL). More specifically, the present invention relates to phakic lenses designed and sized to have a predictable vault for a given eye.

[0007] Description of the Related Art

[0008] One decade has passed since the United States Food and Drug Administration determined that implantation of the VISIAN Implantable Collamer Lens (ICL, STAAR Surgical, Monrovia, CA, USA) is a safe and effective refractive procedure for the correction of myopia (1 ). Worldwide, the VISIAN ICL has been marketed for approximately two decades, and over 550,000 lenses have been implanted (2). The benefits of the ICL for the correction of moderate-to-high myopia and myopic astigmatism (3) include predictable, stable refractive correction (4) and a high efficacy index (5), as well as improvement in quality of vision (6) and quality of life (7). Longterm studies have investigated the safety profile of the ICL and demonstrated generally low rates of adverse events (8). In a prospective, randomized study comparing ICL implantation and photorefractive keratectomy, the ICL performed better than photorefractive keratectomy in all measures of safety, efficacy, predictability, and stability, supporting the ICL as a viable alternative to this popular refractive surgical procedure (6).

[0009] Nevertheless, controversies remain regarding methodology for selection of the implant size, and the relationship of implant size to safety (9). In addition, implantation of the USFDA-approved ICL requires that the surgeon perform preoperative laser iridotomies, which means an additional office visit and possible discomfort for patients. A newer design, currently available outside the United States, the V4c VISIAN ICL with KS Aquaport, VICMO, incorporates a 0.36 mm diameter port in the center of the optic. The presence of this port obviates the need for preoperative iridotomies.

[0010] The ICL is intended for surgical implantation within the posterior chamber of the eye, behind the iris and in front of the crystalline lens. Different sizes of overall diameter are manufactured to accommodate normal variations in intraocular anatomy (eg, 12.1 , 12.6, 13.2, and 13.7 mm). The relationship of the selected overall diameter of the implanted lens to the dimensions of the posterior chamber represents an important determinant of the achieved postoperative vault, which is the term used to describe the measurable distance between the anterior capsule of the crystalline lens and the posterior surface of the ICL. The mechanism of vault is related to the pressure applied on ICL peripheral haptics from the ciliary body and the subsequent forward movement against the iris optical part. The philosophy behind this mechanism is to avoid any touch of the polymer material to the central optical surface of the human lens and the creation of a secondary cataract.

[0011] There has been considerable interest in finding ways to improve sizing, ie, the selection of the best-fit overall diameter of the ICL for a given eye, because optimal sizing is seen as a way to increase the proportion of ICLs within the range of safe vault. The clinical significance of vault outside of the range of safety resides in the risk of specific adverse events, including pupillary block, anterior subcapsular (ASC) cataract, pigment dispersion, and glaucoma. Precise definitions for insufficient vault and excessive vault have, however, remained elusive, because only a percentage of eyes with vault beyond any predefined range experiences vault-related adverse events. While insufficient or excessive vault may be recognized by the occurrence of specific adverse events, eyes with the same degree of vault do not experience these adverse events. Thus, extremes of vault must be viewed as risk factors for adverse events, not as adverse events in and of themselves.

[0012] Thus, there remain unmet needs in the art for sizing and safety of implantable lenses. Particularly, the art is deficient in implantable intraocular lenses designed for seating on the human crystalline lens. The present invention fulfils this longstanding need and desire in the art. SUMMARY OF THE INVENTION

[0013] The present invention is directed to an implantable ocular lens for a human eye. The implantable ocular lens comprises a lens body with a non-optical part and an optical part. The implantable ocular lens comprises means for seating the lens body on an anterior surface of a human crystalline lens and means for securing the lens body within the human eye.

[0014] The present invention also is directed to a phakic lens. The phakic lens comprises a lens body having a substantially non-optical portion surrounding a centrally disposed optical portion. The lens body has four loops extending laterally from a periphery of the substantially non-optical portion and at least four rounded knots formed on a back surface periphery of the non-optical part to extend perpendicularly, downwardly therefrom.

[0015] Other and further aspects, features, and advantages of the present invention will be apparent from the following description of the presently preferred embodiments of the invention. These embodiments are given for the purpose of disclosure.

[0016] BRIEF DESCRIPTION OF THE DRAWINGS

[0017] So that the matter in which the above-recited features, advantages and objects of the invention, as well as others which will become clear, are attained and can be understood in detail, more particular descriptions of the invention briefly summarized above may be had by reference to certain embodiments thereof which are illustrated in the appended drawings. These drawings form a part of the specification. It is to be noted, however, that the appended drawings illustrate preferred embodiments of the invention and therefore are not to be considered limiting in their scope.

[0018] FIG. 1 illustrates a phakic lens and identifies its components.

[0019] FIG. 2 illustrates the placement and securement of the phakic lens in the eye in a cross-sectional view.

[0020] FIGS. 3A-3C show the radial and angular components of the modulation of the posterior surface of the phakic lens to a continuous surface (FIGS. 3A-3B) and the resulting continuous surface (FIG. 3C).

[0021] DETAILED DESCRIPTION OF THE INVENTION

[0022] As used herein, the articles "a" and "an" when used in conjunction with the term “comprising” in the claims and / or the specification, may refer to “one”, but it is also consistent with the meaning of “one or more”, “at least one”, and “one or more than one”. Some embodiments of the invention may consist of or consist essentially of one or more elements, components, method steps, and / or methods of the invention. It is contemplated that any composition, component or method described herein can be implemented with respect to any other composition, component or method described herein.

[0023] As used herein, the term “or” in the claims refers to “and / or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and “and / or”.

[0024] As used herein, the terms "comprise" and "comprising" are used in the inclusive, open sense, meaning that additional elements may be included.

[0025] As used herein, the terms "consist of and "consisting of are used in the exclusive, closed sense, meaning that additional elements may not be included.

[0026] As used herein, the term “about” refers to a numeric value, including, for example, whole numbers, fractions, and percentages, whether or not explicitly indicated. The term “about” generally refers to a range of numerical values (e.g., ± 5- 10% of the recited value) that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In some instances, the term “about” may include numerical values that are rounded to the nearest significant figure.

[0027] As used herein, the terms ’’phakic lens”, “implantable ocular lens”, and “phakic intraocular lens” are interchangeable.

[0028] As used herein, the terms “rounded knots” and “knots” are interchangeable.

[0029] In one embodiment of the present invention there is provided an implantable ocular lens for a human eye, comprising a lens body with a non-optical part and an optical part; means for seating the lens body on an anterior surface of a human crystalline lens; means for securing the lens body within the human eye.

[0030] In this embodiment the implantable ocular lens may be a phakic lens. Also in this embodiment the optical part is centered on the lens body. In an aspect thereof the optical part may have a diameter of about 5 mm to about 9 mm. In addition the lens body may be made of a hydrophobic material or a hydrophilic material. Also in this embodiment the seating means may comprise a plurality of rounded knots formed on a back surface periphery of the non-optical part to extend perpendicularly, downwardly therefrom. Particularly, the plurality of rounded knots is about 4 to about 16. In addition the rounded knots in the plurality have a thickness of about 200 microns to about 500 microns. Furthermore, the rounded knots are made of a hydrophilic material or a hydrophobic material when the lens body is made of, respectively, the hydrophobic material or the hydrophilic material.

[0031] In addition in this embodiment the securing means may comprise a plurality of loops configured for securement within the ciliary sulcus in the eye. Particularly, the loops in the plurality are formed on and extend laterally from the non-optical periphery of the lens body. Also the plurality of loops may be four. In addition the loops in the plurality may have diameters of about 10 mm to about 18 mm. Furthermore, each loop in the plurality may have a mouse ear-like shape.

[0032] In another embodiment of the present invention there is provided a phakic lens, comprising a lens body having a substantially non-optical portion surrounding a centrally disposed optical portion, the lens body having four loops extending laterally from a periphery of the substantially non-optical portion and at least four rounded knots formed on a posterior surface periphery of the non-optical part to extend perpendicularly, downwardly therefrom.

[0033] In this embodiment the optical portion may have a diameter of about 5 mm to about 9 mm. Also in this embodiment the loops may have diameters of about 10 mm to about 18 mm. In addition the loops may have a mouse ear-like shape. Furthermore, the loops may each be configured to secure the lens body within the eye via the ciliary sulcus.

[0034] In an aspect this embodiment the lens body may have four rounded knots to about sixteen rounded knots. In addition the rounded knots in the plurality may have a thickness of about 200 microns to about 500 microns. Also, the rounded loops may be configured to seat the lens body on an anterior surface of a crystalline lens in the eye. In addition the rounded loops may be made of a material different from that of the lens body. Particularly the rounded knots may comprise a hydrophilic material and the lens body may comprise a hydrophobic material. Alternatively, the rounded knots may comprise a hydrophobic material and the lens body may comprise a hydrophilic material. In another aspect the rounded knots may be formed as a continuous modulation of the posterior surface of the phakic lens; where the modulation has an angular term and a radial term.

[0035] Provided herein is a phakic lens or implantable collamer lens that when implanted in the eye is in contact with the human crystalline lens. The phakic lens has a central optical part with a diameter of about 5-9 mm. The phakic lens comprises a means for seating itself on the anterior surface of the crystalline human lens. For example, a plurality of small, rounded knots, such as about 4-16, are formed symmetrically and circumferentially to depend perpendicularly from the peripheral back side of the non-optical anterior surface thereof. The knots may have a thickness of about 200-500 microns. The rounded knots may be made of a material different from the body of the phakic lens. In a non-limiting example, the rounded knots may be made of a hydrophilic material or of a hydrophobic material while the lens body is made of the other material, i.e. the rounded knots are a hydrophilic material and the lens body is a hydrophobic material while the lens body, of the same implantable ocular lens or phakic lens, is a hydrophilic material. Particularly, materials may be, but not limited to, hydrophobic acrylic, silicone, hydrophilic acrylic.

[0036] Alternatively, the knots may be formed as a continuous modulation of the posterior surface of the lens. The modulation incorporates an angular term and a radial term and is performed in a single continuous manufacturing step via lathecutting. This enables easy parametrization of the modulation (knots) in a manufacturing setting when a plurality of curvatures of the carrier surface may be required to achieve the desired optical power.

[0037] The phakic lens comprises means for securing within the eye such that the optical part is maintained in a central position or alignment with the crystalline lens. For example, four rounded loops with a mouse ear-like shape are formed on the periphery of the phakic lens to extend laterally therefrom to fit smoothly within the ciliary sulcus without affecting the position of the optical part. Each loop may have an overall diameter of about 10-18 mm.

[0038] The optical part has a pre-estimated distance in microns at the center when seated on the anterior surface of the crystalline lens. Using anterior chamber optical coherence tomography the normal crystalline lens anterior curvature may be evaluated. Based on the evaluation, the design and size of the optical part may be precisely verified resulting in a safe and predictable vault. In addition the loops are designed for easy placement with the use of a hook under the iris.

[0039] Particularly, embodiments of the present invention are better illustrated with reference to the Figure(s), however, such reference is not meant to limit the present invention in any fashion. The embodiments and variations described in detail herein are to be interpreted by the appended claims and equivalents thereof.

[0040] FIG. 1 is a cross-sectional view of the phakic lens 10. The phakic lens has a lens body 1 with a centered optical part 1a. Loops 2a,b,c,d are formed on and extend from the non-optical periphery 1b of the lens body as a means for securing the phakic lens body within the ciliary sulcus 5 (see FIG.) of the eye. A plurality of rounded knots, represented by 3a,b,c,d, are formed on the non-optical periphery of the back surface of the lens body to depend perpendicularly downwardly therefrom as a means for seating the phakic lens on the crystalline lens.

[0041] FIG. 2 is a cross-sectional view of the phakic lens 10 seated on the human crystalline lens 4 of the eye. The phakic lens is placed behind the iris 6 illustrating how the knots 3b,c,d are seated on the crystalline lens and the securement of the loops 2b, d within the ciliary sulcus 5 while keeping the optical part 1a of the lens body 1 centered over the crystalline lens.

[0042] FIGS. 3A-3C illustrate the manufacture of the posterior surface of the phakic intraocular lens. The posterior surface 10a of the phakic lens 10 is manufactured as a continuous surface comprising an aspheric carrier profile with superimposed peripheral ridges 11a,b,c,d. The carrier surface is defined by an even asphere function of the form:

[0043] „ ■ -cr2j- .

[0044] Z carriers = - Eq. 1 ,

[0045] 1 + V(1 - (1 + fc)c2r2) where a plurality of undulations are introduced (as added elevation) which can be defined as the product of a radial and an angular term: modulation = Rr(r) • T6t(0)....Eq. 2, where the radial and angular terms can be defined as

[0046] Rr(r) = — h ■ exp —a (r — r0)k) Eq. 3, and

[0047] Tg(0) = Si exp(-s(0 - 0j)p) Eq. 4, respectively.

[0048] The values are chosen as h = 0.1 mm, a = 104, s = 700, k=4, p = 4, and the ridge centers are positioned at angular locations 0i = TT / 4, 3TT / 4, 5TT / 4, 7TT / 4, forming a four- fold symmetric pattern. The entire posterior surface, including ridges, is lathe-cut in a single continuous manufacturing step.

[0049] The following references are cited herein.

[0050] 1 . Food and Drug Administration Summary of safety and effectiveness data, STAAR Visian ICL. Date of Notice of Approval. Dec 22, 2005.

[0051] 2. STAAR Surgical Reports Fourth Quarter and Full Year 2015 Results.

[0052] 3. Price MO, Price FW., Jr. Evaluation of the toric implantable collamer lens for simultaneous treatment of myopia and astigmatism. Expert Rev Med Devices. 12(1 ):25-39, 2015.

[0053] 4. Sanders et al., ICL in Treatment of Myopia Study Group United States Food and Drug Administration clinical trial of the implantable collamer lens (ICL) for moderate to high myopia: three-year follow-up. Ophthalmology. 111 (9):1683-1692, 2004.

[0054] 5. Lisa et al., Collagen copolymer posterior chamber phakic intraocular lens supported by the ciliary sulcus to treat myopia: one-year follow-up. J Cataract Refract Surg. 41 (1 ):98— 104, 2015.

[0055] 6. Schallhorn et al., Randomized prospective study of visian implantable Collamer lens and conventional photorefractive keratectomy for moderate to high myopic astigmatism. J Refract Surg. 23:853-857, 2007.

[0056] 7. Leong et al., Quality of life in high myopia before and after implantable Collamer lens implantation. Ophthalmology. 2010;117(12):2295-2300, 2010.

[0057] 8. Sanders DR. Anterior subcapsular opacities and cataracts 5 years after surgery in the visian implantable collamer lens FDA trial. J Refract Surg. 24(6):566- 570, 2008.

[0058] 9. Dougherty et al., Improving accuracy of phakic intraocular lens sizing using high-frequency ultrasound biomicroscopy. J Cataract Refract Surg. 37(1):13-18, 2011.

Claims

WHAT IS CLAIMED IS:1 . An implantable ocular lens for a human eye, comprising: a lens body with a non-optical part and an optical part; means for seating the lens body on an anterior surface of a human crystalline lens; means for securing the lens body within the human eye.

2. The implantable ocular lens of claim 1 , wherein the optical part is centered on the lens body.

3. The implantable ocular lens of claim 1 , wherein the lens body is made of a hydrophobic material or a hydrophilic material.

4. The implantable ocular lens of claim 1 , wherein the optical part has a diameter of about 5 mm to about 9 mm.

5. The implantable ocular lens of claim 1 , wherein the seating means comprises a plurality of rounded knots formed on a back surface periphery of the non- optical part to extend perpendicularly, downwardly therefrom.

6. The implantable ocular lens of claim 5, wherein the plurality of rounded knots is about 4 to about 16.

7. The implantable ocular lens of claim 5, wherein the rounded knots in the plurality have a thickness of about 200 microns to about 500 microns.

8. The implantable ocular lens of claim 5, wherein the rounded knots may be made of a hydrophilic material or a hydrophobic material when the lens body is made of, respectively, the hydrophobic material or of the hydrophilic material.

9. The implantable ocular lens of claim 1 , wherein the securing means comprises a plurality of loops configured for securement within the ciliary sulcus in the eye.

10. The implantable ocular lens of claim 9, wherein the loops in the plurality are formed on and extend laterally from the non-optical periphery of the lens body.11 . The implantable ocular lens of claim 9, wherein the plurality of loops is four.

12. The implantable ocular lens of claim 9, wherein the loops in the plurality have diameters of about 10 mm to about 18 mm.

13. The implantable ocular lens of claim 9, wherein each loop in the plurality has a mouse ear-like shape.

14. The implantable ocular lens of claim 1 that is a phakic lens.

15. A phakic lens, comprising: a lens body having a substantially non-optical portion surrounding a centrally disposed optical portion, said lens body having four loops extending laterally from a periphery of the substantially non-optical portion and at least four rounded knots formed on a posterior surface periphery of the non-optical part to extend perpendicularly, downwardly therefrom.

16. The phakic lens of claim 15, wherein the optical portion has a diameter of about 5 mm to about 9 mm.

17. The phakic lens of claim 15, wherein the loops have diameters of about 10 mm to about 18 mm.

18. The phakic lens of claim 15, wherein the loops have a mouse ear-like shape.

19. The phakic lens of claim 15, wherein the loops are each configured to secure the lens body within the eye via the ciliary sulcus.

20. The phakic lens of claim 15, wherein the lens body has four rounded knots to about sixteen rounded knots.

21. The phakic lens of claim 15, wherein the rounded knots in the plurality have a thickness of about 200 microns to about 500 microns.

22. The phakic lens of claim 15, wherein the rounded loops are configured to seat the lens body on an anterior surface of a crystalline lens in the eye.

23. The phakic lens of claim 15, wherein the rounded knots are made of a material different from that of the lens body.

24. The phakic lens of claim 23, wherein the rounded knots comprise a hydrophilic material and the lens body comprises a hydrophobic material.

25. The phakic lens of claim 23, wherein the rounded knots comprise a hydrophobic material and the lens body comprises a hydrophilic material.

26. The phakic lens of claim 15, wherein the rounded knots are formed as a continuous modulation of the posterior surface of the phakic lens; said modulation having an angular term and a radial term.

Images