Clinical Trial to Assess Safety of Ex Vivo Corneal Cross-Linking in Donor Tissue for High-Risk Corneal Transplants

What this Trial Is About

Researchers are evaluating the safety of Ex Vivo Cross Linking CXL of donor corneal tissue in people who have undergone high-risk penetrating keratoplasty, a type of corneal transplant. This randomized, double-masked, multi-site clinical trial involves 96 participants and focuses on those with vascularized high-risk corneal conditions. The study aims to better understand the safety of this treatment approach over a 24-month period. Participants will be randomly assigned to one of two groups one group will receive donor corneal tissue treated with 0.1% riboflavin Vitamin B2 and 20% dextran Photrexa Viscous & Photrexa combined with UV light, while the other group will receive untreated donor corneal tissue. The treated tissue is prepared by a Corneal Tissue Bank following strict Current-Good-Tissue-Practice CGTP guidelines. Both groups will be monitored for two years after transplantation to track any adverse events. During the study, participants will have regular assessments to monitor safety, graft failure, and graft rejection rates. Researchers will also evaluate the efficacy of the corneal cross linking through image reviews. The trial includes a follow-up period of 24 months post-transplantation to carefully observe outcomes and ensure comprehensive safety monitoring throughout the study duration.

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty