drugset / Trial / NCT02863809

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

NCT02863809

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2017-03-15
Primary completion
2021-06-30
Completion
2021-08-31

Drugs

EvaluationDrugModalityDoseRoute
Background Dextran Unknown 20 %
Background Riboflavin Other / unclassified 0.1 %