Recruiting INTERVENTIONAL NCT06753916

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty (ExCrossV)

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

Sponsor: Massachusetts Eye and Ear Infirmary

Conditions Corneal Transplant Failure

Interventions Corneal Donor Tissue with Cross Linking Corneal Donor Tissue without Cross Linking

Updated 5 times since 2025 Last updated: Apr 17, 2026 Started: Apr 1, 2025 Primary completion: Jan 1, 2028 Completion: Jan 1, 2031

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Corneal Transplant Failure, this trial is actively recruiting participants. The trial is conducted by Massachusetts Eye and Ear Infirmary and has accumulated 5 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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.

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.

Status Flow

Change History

5 versions recorded

Apr 21, 2026 — Present [daily]

Recruiting

Phase: PHASE2 → None
Jan 2026 — Apr 2026 [monthly]

Recruiting PHASE2
Oct 2025 — Jan 2026 [monthly]

Recruiting PHASE2
Aug 2025 — Oct 2025 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
Feb 2025 — Aug 2025 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility 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.

Contact Information

Sponsor contact:

Massachusetts Eye and Ear Infirmary

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Bermuda Run, United States , Boston, United States , Cincinnati, United States , Durham, United States , Indianapolis, United States , Irvine, United States , Los Angeles, United States , Miami, United States , Overland Park, United States and 2 more locations