Injectable intraocular lens

Abstract

The present invention relates to polysiloxanes suitable for the preparation of intraocular lenses by a crosslinking reaction, having a specific gravity of greater than about 1.0, a refractive index suitable for restoring the refractive power of the natural crystalline lens and a viscosity suitable for injection through a standard cannula. The present invention includes an injectable intraocular lens material based on said polysiloxanes and methods of preparing intraocular lenses by direct injection into the capsular bag of the eye.

Description

[0001] The present invention relates to an intraocular lens and to materials useful in making intraocular lenses (IOLs), specifically, injectable IOLs and methods for their preparation. More particularly, the invention relates to high specific gravity silicone materials suitable for making accommodative IOLs, which can be injected into the capsular bag with greater convenience than previously suggested materials.[0002] The human eye is a highly evolved and complex sensory organ. It is composed of a cornea, or clear outer tissue which refracts light rays enroute to the pupil, an iris which controls the size of the pupil thus regulating the amount of light entering the eye, and a lens which focuses the incoming light through the vitreous fluid to the retina. The retina converts the incoming light into electrical energy that is transmitted through the brain stem to the occipital cortex resulting in a visual image. In the perfect eye the light path from the cornea, through the lens and ...

AI Technical Summary

Benefits of technology

[0030] The present invention improves considerably on previously suggested polysiloxane based materials for injectable IOLs due to its increased specific gravity to above 1.0, so displace residual water after its injection into the capsular sac's aqueous environment. This chacteristic will reduce post-injection manipulation of the surgeon and will assure that the lens will assume a natural position and configuration. In accordance with the methods of the present invention an injectable IOL material is formed that greatly simplifies the injection, positioning and curing process. By the mentioned selection of siloxane monomers a high density injectable material can be provided with a controlled suitable refractive index comparable to that of the natural lens without compromising the other important requirements including a viscosity suitable for injection. This will greatly contribute to that is possible to adjust the refractive outcome of the injected lens formed with the capsular bag as a mold by having suitable fractions of siloxane units contributing to a high refractive index and siloxane units contributing to a high density. Another advantage of this invention is that extremely compliant nature fully cured lenses can be obtained. If a conventional foldable silicone lens is considered to have a stiffness of 100, a cured injectable lens made from the material of the present invention could be designed to have a stiffness ranging from zero to five. Therefore, lenses made from the material described herein can be accommodative and respond naturally to the changes in the eyes' shape as focal length is adjusted. The accommodative nature of lenses fabricated from materials of the present invention would make them particularly suitable for corrective purposes besides replacements for diseased natural lenses and is considered within the scope of this invention. An unexpected, and beneficial, advantage of the present invention is the optically smooth surface formed after the lens has cured in situ.

Problems solved by technology

Any obstruction or loss in clarity within these structures causes scattering or absorption of light rays resulting in diminished visual acuity.

For example, the cornea can become damaged resulting in oedema, scarring or abrasions, the lens is susceptible to oxidative damage, trauma and infection, and the vitreous can become cloudy due to hemorrhage or inflammation.

As the body ages, the effects of oxidative damage caused by environmental exposure and endogenous free radical production accumulate resulting in a loss of lens flexibility and denatured proteins that slowly coagulate reducing lens transparency.

Regardless of the cause, the disease results in impaired vision and may lead to blindness.

However, without a lens the eye is unable to focus the incoming light on the retina.

Cataract glasses have thick lenses, are uncomfortably heavy and cause vision artifacts such as central image magnification and side vision distortion.

Contact lenses resolve many of the problems associated with glasses, but require frequent cleaning, are difficult to handle (especially for elderly patients with symptoms of arthritis), and are not suited for persons who have restricted tear production.

This type of lenses requires a large surgical incision in the capsular bag and is not accommodative.

The large incision results in protracted recovery times and the likelihood of introducing astigmatism.

Occasionally, the folding of the lens before insertion results in permanent deformation adversely effecting the implant's optical qualities.

Foldable lenses meet the requirement of reducing the large surgical incision non-deformable lenses required, but are not accommodative.

Moreover, both non-deformable and foldable IOLs are susceptible to mechanical dislocation resulting in damage to the corneal endothelium.

The primary drawback to the thermoplastic lens is the limited number of polymers that meet the exacting needs of this approach.

However, once fully rehydrated the polymer structure is notoriously weak due to the large amount of water absorbed.

Apart from problems with obtaining control over the crosslinking process and finding clinically acceptable conditions, there have been a struggle to perfect the polyorganosiloxane compositions, since they need to have a suitable viscosity for injection, a suitably high refractive index as well as suitable mechanical characteristics after crosslinking, i.e. a suitable modulus.

PDMS has also been found to have a relatively low viscosity and thereby a tendency to leak out of out of the desired injection site (i.e. the capsular bag).

However, high viscosity silicones have the drawback in that they can entrap air bubbles, which can impair the optical quality of the resulting product.

In addition, it has been found that polyorganosiloxanes having a high fraction of dimethylsiloxane units may have an unacceptable low specific gravity with the undesired result that the injected lens material will float on an aqueous layer in the capsular bag.

In such a case, it will be difficult to fill the capsular sac completely and requires the surgeon to manually express water in order to maintain the correct lens shape during the curing process.

Images