ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
ConditionCorneal Transplant Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Corneal Donor Tissue with Cross Linking
- Corneal Donor Tissue without Cross Linking
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov