NCT06753916 · Massachusetts Eye and Ear Infirmary
ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
(ExCrossV)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Determining the Primary Safety of Corneal Cross Linking
Time frame: 24 Months
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 and older
- Willing and able to provide written informed consent
- Willing and able to comply with study assessments for the full duration of the study
- Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft
- Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma). Superficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with \>2 quadrants of superficial vessels (\>6 clock hours) or 1 quadrant of deep vessels (\>3 clock hours) as severe (36).
Exclusion criteria
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Ocular or periocular malignancy
- Non-healing epithelial defect of at least 0.5x0.5 mm in host
Where
- Irvine, California
- Los Angeles, California
- San Francisco, California
- Miami, Florida
- Indianapolis, Indiana
- Overland Park, Kansas
- Towson, Maryland
- Boston, Massachusetts
- Ann Arbor, Michigan
- Bermuda Run, North Carolina
- Durham, North Carolina
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations