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WO-2026096610-A1 - PHAKIC LENSES

WO2026096610A1WO 2026096610 A1WO2026096610 A1WO 2026096610A1WO-2026096610-A1

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.

Inventors

  • PALLIKARIS, IOANNIS
  • HARILAOS, GINIS

Assignees

  • CRETECH B.V.
  • ADLER, Benjamin Aaron

Dates

Publication Date
20260507
Application Date
20251029
Priority Date
20241030

Claims (20)

  1. 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. 2. The implantable ocular lens of claim 1 , wherein the optical part is centered on the lens body.
  3. 3. The implantable ocular lens of claim 1 , wherein the lens body is made of a hydrophobic material or a hydrophilic material.
  4. 4. The implantable ocular lens of claim 1 , wherein the optical part has a diameter of about 5 mm to about 9 mm.
  5. 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. 6. The implantable ocular lens of claim 5, wherein the plurality of rounded knots is about 4 to about 16.
  7. 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. 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. 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. 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. 11 . The implantable ocular lens of claim 9, wherein the plurality of loops is four.
  12. 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. 13. The implantable ocular lens of claim 9, wherein each loop in the plurality has a mouse ear-like shape.
  14. 14. The implantable ocular lens of claim 1 that is a phakic lens.
  15. 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. 16. The phakic lens of claim 15, wherein the optical portion has a diameter of about 5 mm to about 9 mm.
  17. 17. The phakic lens of claim 15, wherein the loops have diameters of about 10 mm to about 18 mm.
  18. 18. The phakic lens of claim 15, wherein the loops have a mouse ear-like shape.
  19. 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. 20. The phakic lens of claim 15, wherein the lens body has four rounded knots to about sixteen rounded knots.

Description

PHAKIC LENSES Cross-Reference to Related Applications 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. BACKGROUND OF THE INVENTION Field of the Invention 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. Description of the Related Art 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). 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. 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. 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. 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 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. The present invention also is directed to a phakic lens. The phakic lens comprises a lens body having a substant