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RECRUITING
NCT06753916
PHASE2

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Sponsor: Massachusetts Eye and Ear Infirmary

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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.

PROCEDURE

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