Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Eye prosthesis – Intraocular lens
Reexamination Certificate
2000-08-23
2002-11-19
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Eye prosthesis
Intraocular lens
C623S006160
Reexamination Certificate
active
06482230
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to intraocular lenses. In particular, the present invention relates to methods for determining whether intraocular lens materials have a propensity for preventing 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. Nos. 5,576,345 (pharmaceutical agent=the cytotoxic agent taxol or an ophthalmically acceptable derivative); 4,515,794; and 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 method of determining the propensity of an intraocular lens (“IOL”) material to prevent posterior capsule opacification (“PCO”). The method involves contacting a sample of the IOL material having the shape of an IOL optic with collagen material thereby defining a contact area, incubating the sample in a liquid composition comprising lens epithelial cells (“LECs”), and determining whether any LECs grow on the collagen surface in the contact area.
The present invention also relates to IOL materials having reduced risk of PCO. Without intending to be bound by any theory, it is believed that an IOL material that adheres strongly to collagen upon contacting collagen prevents or inhibits LEC growth in the area between the collagen and the IOL material.
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Nagata et al., “Adhesiveness of Acry
Chan Kwan
Karakelle Mutlu
Sheets, Jr. John W.
Alcon Manufacturing Ltd.
Blanco Javier G.
Ryan Patrick M.
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