In recent years, major emphasis has been placed on developing a biopolymer material, which could be injected into the natural lens capsule following cataract extraction. In order to fill the natural lens capsule with such a biopolymer lens substitute, the diseased cataract must first be removed via an endocapsular cataract extraction. The phacoemulsification procedure requires destruction (removal) of the anterior lens capsule, precluding use of future biopolymer lens refilling technologies. Optex has developed an innovative proprietary Endocapsular Vortex Emulsification (EVE) technology for endocapsular cataract removal. EVE is the first technology to offer the potential of providing a user-friendly, fast, economical and commercially viable procedure for performing endocapsular cataract removal. Scientific studies have demonstrated that lens material can be removed from the lens capsule via a 1.25-1.5 mm hole in less than 5 minutes (generally 1-3 minutes) using the EVE technology. Therefore, use of the EVE technology for cataract removal would allow the lens capsule to be basically intact so it can be filled with a biopolymer after cataract removal.
The specific aims of this proposed research for advancing the EVE technology for cataract removal toward commercialization are as follows: 1) Develop clinical instrument system design including disposable (sterile, single use), responsible (limited reuse), and reusable (extended use) components. This clinical instrument system will serve as the basis for regulatory submissions to FDA and clinical studies. 2) Fabricate clinical instrument system, 3) Develop excised cadaver eye model, 4) Perform experimental studies to select and optimize clinical instrument system operating parameters, and 5) Demonstrate safety and efficacy and ease-of-use of the clinical instrument.
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