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CA-3185169-C - INTRAOCULAR LENS INCLUDING SILICONE OIL

CA3185169CCA 3185169 CCA3185169 CCA 3185169CCA-3185169-C

Abstract

An intraocular lens (IOL) having an optical axis extending in an anterior-posterior direction and an equator extending in a plane substantially perpendicular to the optical axis is described. The IOL includes: an elastic anterior face located anterior to the equator; a posterior face located posterior to the equator, wherein the anterior face, the posterior face, or both comprises a poly(dimethylsiloxane) elastomer having a durometer between about 20 Shore A to about 50 Shore A; and a chamber located between the anterior face and the posterior face comprising a silicone oil comprising polysiloxanes comprising diphenyl siloxane and dimethyl siloxane units, the silicone oil having a maximum viscosity of about 800 cSt at 25 °C.

Inventors

  • Forrest J. Ellis

Assignees

  • JelliSee Ophthalmics Inc.

Dates

Publication Date
20260505
Application Date
20210717
Priority Date
20200717

Claims (12)

  1. 26 What is claimed is: 1. An intraocular lens (IOL) having an optical axis extending in an anterior-posterior direction and an equator extending in a plane substantially perpendicular to the optical axis, the IOL comprising: an elastic anterior face located anterior to the equator; a posterior face located posterior to the equator, wherein the anterior face, the posterior face, or both comprises a poly(dimethylsiloxane) elastomer having a durometer between about 20 Shore A to about 50 Shore A; and a chamber located between the anterior face and the posterior face comprising a silicone oil comprising polysiloxane comprising diphenyl siloxane and dimethyl siloxane units, the silicone oil having a maximum viscosity of 800 cSt at 25 ºC, wherein the silicone oil has a mean molecular weight from about 1,000 to about 3,000 Daltons.
  2. 2. The IOL of claim 1, wherein the poly(dimethylsiloxane) elastomer has a durometer of about 50 Shore A.
  3. 3. The IOL of claim 1 or 2, further comprising an elastic side wall extending across the equator and extending from the anterior face to the posterior face.
  4. 4. The IOL of any one of claims 1 to 3, wherein the anterior and posterior face of the IOL comprise polysiloxane that is at least 99% poly(dimethylsiloxane) elastomer.
  5. 5. The IOL of any one of claims 1 to 4, wherein the anterior face and the posterior face have one or more surfaces that are smooth.
  6. 6. The IOL of any one of claims 1 to 5, wherein at least a portion of the anterior face and the posterior face are coated with a layer of parylene.
  7. 7. The IOL of any one of claims 1 to 6, wherein the polysiloxane comprises at least 10 mol% diphenyl siloxane.
  8. 8. The IOL of any one of claims 1 to 7, wherein the silicone oil comprises about 30 mol% diphenyl siloxane and about 70 mol% dimethyl siloxane. 27
  9. 9. The IOL of any one of claims 1 to 8, wherein the silicone oil comprises from about 5% to about 10% long chain polysiloxane molecules by weight.
  10. 10. The IOL of any one of claims 1 to 9, wherein the silicone oil has a viscosity between about 400 cSt at 25ºC to about 800 cSt at 25ºC.
  11. 11. The IOL of any one of claims 1 to 10, wherein the silicone oil has a refractive index between 1.49-1.53.
  12. 12. The IOL of any one of claims 1 to 11, wherein the silicone oil comprises less than 0.1% octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and dodecamethylcyclohexasiloxone.

Description

1 INTRAOCULAR LENS INCLUDING SILICONE OIL CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application is related to U.S. Provisional Application No. 63/053,134, filed on July 17, 2020. TECHNICAL FIELD [0002] The present disclosure relates to an accommodative intraocular lens that includes a chamber comprising a silicone oil comprising polysiloxanes comprising diphenyl siloxane and dimethyl siloxane units that improve the response time of the intraocular lens. BACKGROUND [0003] The human crystalline lens can be affected by one or more disorders or conditions that reduces its function and/or reduces the clarity of the lens. A common condition that occurs with aging is the gradual opacification and reduced transparency of the lens of the eye. This condition is termed a cataract. Surgical removal of a cataractous lens and placement of an artificial replacement lens (such as an intraocular lens (“IOL”)) within the eye is a common surgical procedure. The development of a suitable IOL that can provide the optical quality and accommodation provided by the youthful biological lens has not been developed. [0004] There are generally two classes of IOLs that have been developed that attempt to overcome the lack of accommodation of an IOL used to replace the natural lens when cataract surgery is performed: pseudo-accommodating lenses and accommodating lenses. A pseudoaccommodating lens can be a multiple focal point lens that uses a ring for distance focus and one or more center optics for intermediate and near focus. Other designs use diffraction optics to obtain a range of focus or use optics to achieve an extended depth of focus (EDOF). Multi-focus optics, diffraction optics, and EDOF optic IOLs can result in disruptive optical aberrations such as glare, halos, reduced contrast sensitivity, etc. Centration of these lenses within the capsular bag is important to their best visual function. These lenses use nondeforming optical elements and do not achieve the visual quality of a natural, youthful lens of 9 of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects and embodiments of the disclosure including patent applications referenced herein. [0040] Unlike shape changing accommodating IOLs described by way of background, IOLs are provided herein that can mimic the gradient elastic properties of a natural youthful human lens during accommodation and include a shape-changing optic where components of the optic change shape as the IOL transitions from an accommodated state to a dis-accommodated state and vice versa. Without wishing to be bound by a specific mechanism of action, it is considered by some that the lens capsules’ “elasticity” controls and shapes the lens as a whole (the lens nucleus and cortex). On this basis, the lens contents are considered pliable. However, the volume of the lens contents compared to the thickness and known modulus of elasticity of the lens capsule predicts that the lens capsule cannot solely control and alter the shape of the lens nucleus and cortex. Finite element analysis (FEA) predicts that radial tension about the equatorial region of a lens capsule filled with a soft pliable solid or liquid does not result in significant shape change to either the anterior or posterior surface of the lens compared to what is known to occur with the natural youthful human lens. Providing radial tension directed specifically to at least the anterior face of an accommodating IOL; having that tension directed at points anterior to the equator of the IOL; the anterior face of the IOL being more resistant to deformational change than the content(s) of a chamber underlying the anterior face; the anterior face demonstrating elastic properties in so much as the anterior face deforms when a force is applied to the anterior face and the anterior face will return to its original shape with the removal of the force, results in a greater amount of anterior face shape change and therefore accommodating dioptric power change than can be achieved with a similar force applied at points at or more near the equator of the IOL (e.g. equatorial). In addition, a force applied to the anterior face at points anterior to the equator of the IOL requires less diameter change of the anterior face per diopter of power change of the IOL compared to a similar force applied at points at or more near the equator of the IOL thereby allowing the anterior face of the IOL to shape change even with very small amounts of anterior face diameter change when going from an accommodated state, a dis-accommodated state, and states in between. [0041] In particular, in an aspect, an IOL comprising a shape changing optic that can assume an accommodated state, a dis-accommodated state, and states therebetween is provided. 19 comprises a polysiloxane that is at least 99% poly(dimethylsiloxane), in addition to the posterior face and/or anterior face having this % p