At a glance
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A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation
In Brief
A Phase 2 clinical trial evaluating Riboflavin, Dextran, and 1 other intervention for Keratolysis. Completed, enrolled 76 participants across 13 sites.
Detailed Summary
This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.
Study Details
Timeline
Interventions
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Dextran is used to increase the viscosity of the solution.
Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.