ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
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
Massachusetts Eye and Ear Infirmary
96 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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 corneal bed lasting ≥6 weeks preoperatively
- Uncontrolled glaucoma
- Change in topical corticosteroid regimen within 14 days of transplantation
- Use of systemic immunosuppressive for indication other than corneal graft rejection
- Participation in another simultaneous medical investigation or trial
- Pregnancy (positive pregnancy test) or lactating
- Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
- Ocular infection within 30 days prior to study entry.
- Presence of anterior chamber intraocular lens
- Active uveitis within 90 days prior to the study entry.
- No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.
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Interventions
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.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06753916