Research Project
6549370
DESCRIPTION (provided by applicant): Anamed has developed PermaVisionr intracorneal implants for the correction of refractive errors, specifically, hyperopia from +1D to +6D. These implants are made from a selected proprietary Nutraporer micro-porous hydrogel that allows transport of fluid and nutrients satisfying the needs of the human cornea. There is no permanent solution for hyperopia today. Implantation is done using a procedure to be called Sutureless Synthetic Keratophakia (SSKTM). This involves lamellar dissection to generate a flap (like in LASIK surgery), placing the lens on the stromal bed and closing the flap without sutures. Rehabilitation is quick. The power of the lens is predefined and pre-tested during manufacturing so the surgeon can accurately correct the power in one sitting. The procedure is reversible and adjustable. Improper power correction/lens placement can easily be corrected by re-lifting the flap and replacing/repositioning the lens. During Phase II we propose to develop final lens design(s), manufacture clinical supplies, conduct a Phase I clinical trial under an approved USFDA-IDE, develop commercial packaging and sterilization process, determine shelf life and photo-stability, select a marking material/method to confirm proper lens placement/orientation which was found difficult during the one year GLP swine study (completed), develop commercial manufacturing process(es), and perform validations.
