ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
Start Date
4/1/2025
Completion Date
1/1/2031
Summary
The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.
Detailed Description
This is a randomized, double-masked, multi site clinical trial to determine the safety of Ex Vivo CXL of donor corneal tissue in 96 participants who have undergone high-risk penetrating keratoplasty. Participants will be randomized to receive either a corneal tissue that has been untreated vs. a corneal tissue that has been treated with Photrexa® Viscous \& Photrexa® and UV light. The tissue will be prepared by a Corneal Tissue Bank under Current-Good-Tissue-Practice (CGTP) and delivered to the respective institutions for transplantation. Participants will be monitored up to 24 months post-transplantation to assess for adverse events of the randomized tissue.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Corneal Donor Tissue with Cross Linking
Corneal Donor Tissue without Cross Linking
Conditions
Locations
University of California Irvine - Gavin Herbert Eye Institute
Irvine, California 92617
United States
The University of California Los Angeles - Doris Stein Eye Research Center
Los Angeles, California 90095
United States
University of California San Francisco - Wayne and Gladys Valley Center for Vision
San Francisco, California 94158
United States
University of Miami - Bascom Palmer Eye Institute
Miami, Florida 33136
United States
Price Vision Group
Indianapolis, Indiana 46260
United States
Kansas City Eye Clinic
Overland Park, Kansas 66204
United States
Mid-Atlantic Cornea Consultant
Towson, Maryland 21204
United States
Massachusetts Eye and Ear
Boston, Massachusetts 02114
United States
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan 48015
United States
Wake Forest Baptist Eye Center
Bermuda Run, North Carolina 27006
United States
Duke University - Duke Eye Center
Durham, North Carolina 27705
United States
Cincinnati Eye Institute
Cincinnati, Ohio 45242
United States