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ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

NCT06753916 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Corneal Transplant Failure

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.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Joseph Ciolino, MD · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2028-01-01
Completion
2031-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06753916 on ClinicalTrials.gov