Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA
Dates
study started
study ends around
Principal Investigator
by Anthony Aldave, MD (ucla)

Description

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

Details

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.

Keywords

Corneal Transplant Failure, Keratoplasty, Cross Linking, Corneal Donor Tissue with Cross Linking, Corneal Donor Tissue without Cross Linking

Eligibility

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

Lead Scientist at University of California Health

  • Anthony Aldave, MD (ucla)
    Dr. Anthony J. Aldave holds the Bartly J. Mondino, M.D., Endowed Chair in Ophthalmology. He previously held the Walton Li Chair in Cornea and Uveitis (4/1/2014 - 6/30/2023).

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts Eye and Ear Infirmary
ID
NCT06753916
Phase
Phase 2 Corneal Transplantation Research Study
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated