Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
1999-04-01
2001-04-03
Prebilic, Paul B. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C523S106000
Reexamination Certificate
active
06210438
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to intraocular lenses. In particular, the present invention relates to a method of preparing a bicomposite intraocular lens material comprising a posterior surface for reducing the risk of posterior capsule opacification.
BACKGROUND OF THE INVENTION
Foldable intraocular lens (“IOL”) materials can generally be divided into three categories: silicone materials, hydrogel materials, and non-hydrogel acrylic materials. Many materials in each category are known. See, for example,
Foldable Intraocular Lenses
, Ed. Martin et al., Slack Incorporated, Thorofare, N.J. (1993). Biocompatibility varies among different IOL materials within and among each category.
One measure of biocompatability for an IOL can be the incidence of posterior capsule opacification (“PCO”). A number or factors may be involved in causing and/or controlling PCO. For example, the design and edge sharpness of an IOL may be a factor. See, Nagamoto et al., J. Cataract Refract. Surg., 23:866-872 (1997); and Nagata et al., Jpn. J. Ophthalmol., 40:397-403 (1996). See, also, U.S. Pat. Nos. 5,549,670 and 5,693,094. Another factor appears to be the lens material itself. See, for example, Mandle, “Acrylic lenses cause less posterior capsule opacification than PMMA, silicone IOLs, ” Ocular Surgery News, Vol. 14. No. 15, p. 23 (1996). See, also, Oshika, et al., “Two Year Clinical Study of a Soft Acrylic Intraocular Lens, ” J. Cataract. Refract. Surg., 22:104-109 (1996); and Ursell et al., “Relationship Between Intraocular Lens Biomaterials and Posterior Capsule Opacification, ” J. Cataract Refract. Surg., 24:352-360 (1998).
One method of addressing the PCO problem involves administering a pharmaceutical agent to the capsular bag area at the time of, or immediately after, extracapsular cataract extraction. See, for example, U.S. Pat. No. 5,576,345 (pharmaceutical agent=the cytotoxic agent taxol or an ophthalmically acceptable derivative); U.S. Pat. No. 4,515,794; and U.S. Pat. No. 5,370,687. Alternatively, the pharmaceutical agent may be tethered to the surface of the IOL material. See, for example, U.S. Pat. No. 4,918,165. The pharmaceutical agents are intended to kill or prevent the growth of proliferating cells that might cause PCO or “secondary cataracts. ” Yet another method involves the physical destruction or removal of lens epithelial cells. See, Saika et al., J. Cataract Refract. Surg., 23:1528-1531 (1997).
Another method of addressing PCO is the prophylactic laser therapy method disclosed in U.S. Pat. No. 5,733,276. According to this method, the lens capsule is irradiated with laser irradiation to destroy cells which remain in the lens capsule after extraction of a cataract.
Other methods theorized for reducing the risk of PCO involve adhering the posterior capsule to the IOL at the time of implantation, as in U.S. Pat. No. 5,002,571. According to the '571 patent, a non-biological glue or, preferably, a biological glue, such as fibrin, collagen, or mussel glue, is used to adhere the posterior lens capsule to the posterior surface of an IOL. The glue may be applied over the entire posterior surface of the IOL or just as an annulus around the outer perimeter of the posterior surface of the IOL.
In contrast, U.S. Pat. No. 5,375,611 discloses a method of reducing the risk of PCO by preventing the adherence of the posterior capsule to the IOL. According to the '611 patent, the posterior surface of the lens capsule itself is chemically modified at the time of extracapsular cataract extraction. The chemical modification is achieved by depositing a water-insoluble stable or permanent layer of a cell attachment preventing compound onto the posterior surface of the lens capsule. The stable or permanent layer may be a polymer, such as polyethylene glycol, polysaccharides, polyethylenepropylene glycol, and polyvinyl alcohols.
SUMMARY OF THE INVENTION
The present invention relates to a bicomposite intraocular lens and a method for its preparation. According to the present invention, a bicomposite IOL optic comprising an anterior surface material consisting of an ophthalmically acceptable lens-forming material and a posterior surface material, different from the anterior surface material, for reducing the risk of posterior capsule opacification is prepared. The posterior surface material consists essentially of two or more aryl acrylic hydrophobic monomers. The method comprises the steps of (a) forming a posterior surface layer of material by polymerizing a posterior surface material composition consisting essentially of two or more aryl acrylic hydrophobic monomers and a cross-linking agent in a mold having the desired IOL posterior surface shape; (b) forming an anterior surface layer by adding a liquid anterior composition consisting of an ophthalmically acceptable IOL material to the top of the posterior surface layer and polymerizing the liquid anterior composition.
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Karakelle Mutlu
LeBoeuf Albert R.
Patel Anilbhai S.
Sheets, Jr. John W.
Van Noy Stephen J.
Alcon Laboratories Inc.
Prebilic Paul B.
Ryan Patrick M.
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