LASER SYSTEM FOR PHOTOTHERMAL INTRASTROMAL KERATOPLASTY

WE WILL DEVELOP A LASER SYSTEM THAT IS SUITABLE FOR PERFORMING PHOTOTHERMAL INTRASTROMAL KERATOPLASTY TO CORRECT OCULAR REFRACTIVE ERRORS. LASER PARAMETERS (WAVELENGTH, IRRADIANCE, AND IRRADIATION TIME) AND DELIVERY/GEOMETRY PARAMETERS (BEAM PROFILE, SPOT SIZE, PATTERN, AND SLEW RATE) SHALL BE OPTIMIZED FOR TREATMENT OF MYOPIA, HYPEROPIA, AND ASTIGMATISM. IN THE PHASE I PROGRAM RESEARCH, A PROTOTYPE LASER SYSTEM SHALL BE CONSTRUCTED AND EVALUATED FOR ITS UTILITY IN PRODUCING SAFE AND EFFECTIVE PHOTOTHERMAL INTRASTROMAL KERATOPLASTY IN ANIMAL AND HUMAN CORNEA SPECIMENS. THE PROTOTYPE SYSTEM SHALL INCLUDE A LASER SOURCE, BEAM DELIVERY MEANS, BEAM DIAGNOSTICS, A COUPLING MEANS TO PREVENT DAMAGE TO ANTERIOR CORNEAL MICROSTRUCTURES, OCULAR DIAGNOSTICS, AND A CONTROL SUBSYSTEM. THE PROTOTYPE SYSTEM SHALL BE USED IN VITRO (SWINE AND HUMAN) AND IN VIVO (RABBIT) EXPERIMENTS TO DEMONSTRATE THE FEASIBILITY OF OBTAINING CONTROLLED AND ACCURATE CHANGES IN CORNEAL TOPOGRAPHY WITHOUT INDUCING CLINICALLY SIGNIFICANT DAMAGE. IN THE PHASE II PROGRAM RESEARCH, THE PROTOTYPE LASER SYSTEM SHALL BE DEVELOPED FURTHER AND OPTIMIZED FOR CLINICAL APPLICATIONS. THE DEVICE AND PROTOCOL SHALL BE REFINED TO ACHIEVE SAFE, EFFECTIVE, PREDICTABLE, AND STABLE REFRACTIVE SURGICAL RESULTS. ISSUES RELATED TO ROUTINE AND DEPENDABLE USE IN A CLINICAL ENVIRONMENT (SUCH AS SYSTEM SIZE AND PACKAGING, FIBER OPTIC DELIVERY OF LASER RADIATION THROUGH A SLIT LAMP, AND EASE OF USE) SHALL BE ADDRESSED IN ORDER TO PRODUCE A BROADLY USEFUL SYSTEM. IF THE PHASE II RESEARCH IS SUCCESSFUL, PHASE III COMMERCIALIZATION SHALL BE FUNDED BY ANTROPIX AND OTHER PRIVATE INVESTORS. THE ULTIMATE GOAL OF THE PROGRAM IS THE DEVELOPMENT OF A NEW CLINICAL DEVICE AND PROTOCOL FOR SAFE AND EFFECTIVE LASER PHOTOTHERMAL INTRASTROMAL KERATOPLASTY FOR CORRECTION OF OCULAR REFRACTIVE ERRORS.