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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
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.
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.
University of California Irvine - Gavin Herbert Eye Institute
Irvine, California, United States
NOT_YET_RECRUITINGThe University of California Los Angeles - Doris Stein Eye Research Center
Los Angeles, California, United States
Determining the Primary Safety of Corneal Cross Linking
The occurrence of adverse events throughout study including: 1. Ocular Safety per the incidences and severity of ocular adverse events during the study based on ophthalmic examination and participants' self-report. 2. Short Term Safety Events (Post Surgery \< 1 Month) * Post-Op Microbial Keratitis * Acute Rejection (Epithelial, Endothelial, Sub epithelial, or Mixed) 3. Long Term Safety Events (Post Surgery \> 1 Month) * Rejection (Epithelial, Endothelial, or Mixed) * Graft Failure * Ulcerative Keratitis * Persistent Epithelial Defect lasting more than 6 Weeks
Time frame: 24 Months
Measure of the Frequency of Graft Failures though Corneal Cross Linking
To determine the efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the frequency of primary graft failures over 24 months.
Time frame: 24 Months
Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months
The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the time from surgery to overall graft failure (regardless of cause).
Time frame: 24 Months
Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months
The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the occurrence of any rejection episode. (Epithelial, Endothelia, Sub Epithelial, or Mixed) determined as either definite rejection, probably rejection, and possible rejection, from the time of surgery over 24 months.
Time frame: 24 Months
Nikolay Boychev, OD, PhD
CONTACT
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University of California San Francisco - Wayne and Gladys Valley Center for Vision
San Francisco, California, United States
NOT_YET_RECRUITINGUniversity of Miami - Bascom Palmer Eye Institute
Miami, Florida, United States
RECRUITINGPrice Vision Group
Indianapolis, Indiana, United States
RECRUITINGKansas City Eye Clinic
Overland Park, Kansas, United States
NOT_YET_RECRUITINGMid-Atlantic Cornea Consultant
Towson, Maryland, United States
NOT_YET_RECRUITINGMassachusetts Eye and Ear
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGWake Forest Baptist Eye Center
Bermuda Run, North Carolina, United States
NOT_YET_RECRUITING...and 2 more locations
Measure of the Efficacy of Corneal Cross Linking Through Image Review
The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization. 1\. Corneal Neovascularization (CNV) measured and analyzed from slit-lamp photography.
Time frame: 24 Months