The performance relative to the cost of ophthalmic slitting knives is poor. There exist inexpensive (approximately 25 dollars) disposable, and expensive (approximately 2500 dollars) diamond knives. The disposable knife performance is poor relative to the diamond knife. Diamond knives, in addition to being extremely expensive, are fragile and costly to repair. An alternate to both disposable and diamond knives is a disposable knife coated with a material having properties similar to diamond; we have already demonstrated a factor of seven increase in blade performance and lifetime using such a coating. However, the biocompatibility and toxicity of this material has not been determined in ophthalmic applications. Furthermore, the American Society for Testing and Materials or other similar testing organizations list no standard quantitative technique to assess the relative efficacy of different coatings as friction reducing, wear resistant materials for ophthalmic applications. We propose to 1) determine the biocompatibility and toxicity of this material with structures of the anterior segment of the eye using live cats, and 2) develop a test instrument to quantitatively measure coated ophthalmic knife performance. If biocompatible and non-toxic, this material has many other applications, e.g., radial keratonomy knives. Phase II will include coating performance optimization, manufacturing scale up, and clinical trials. PROPOSED COMMERCIAL APPLICATION High performance knives, e.g., ophthalmic slitting knives, radial keratotomy knives, microscopy keratomes.
