The overall objective of this project is to develop an artificial full- thickness corneal graft to replace damaged cornea in millions of people who suffer from blindness due to damaged or diseased cornea.
The specific aims of Phase I are to fabricate prototype grafts composed of a clear, soluble collagen core surrounded by a peripheral ring, or skirt, containing' intact collagen fibers embedded in soluble collagen. Preliminary evaluations in the rabbit model have demonstrated biocompatibility, rapid healing of the host-graft junction, variable re- epithelialization, and reasonable optical stability. However, additional development is needed to improve and demonstrate optical and biological stability of the optic core, provide consistent reepithelialization of the entire graft, and show long-term biocompatibility in animal models. Results from Phase I will lead to more extensive and longer-term evaluations in animal models. These results will be necessary for submitting appropriate applications to FDA to initiate phased, human clinical trials.
