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ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
Sponsor: Massachusetts Eye and Ear Infirmary
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.
Official title: Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Ex Vivo Corneal Cross-linking of Donor Corneal Tissue Used for Vascularized High-risk Keratoplasty
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-04-01
Completion Date
2031-01-01
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
Corneal Donor Tissue with Cross Linking
Participants are transplanted with corneal donor tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) with UV light treatment.
Corneal Donor Tissue without Cross Linking
Participants are transplanted with corneal donor tissue that has not been treated with the UV light and the 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) without UV light treatment, this is the control group.
Locations (12)
University of California Irvine - Gavin Herbert Eye Institute
Irvine, California, United States
The University of California Los Angeles - Doris Stein Eye Research Center
Los Angeles, California, United States
University of California San Francisco - Wayne and Gladys Valley Center for Vision
San Francisco, California, United States
University of Miami - Bascom Palmer Eye Institute
Miami, Florida, United States
Price Vision Group
Indianapolis, Indiana, United States
Kansas City Eye Clinic
Overland Park, Kansas, United States
Mid-Atlantic Cornea Consultant
Towson, Maryland, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, United States
Wake Forest Baptist Eye Center
Bermuda Run, North Carolina, United States
Duke University - Duke Eye Center
Durham, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States