Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Corneal Donor Tissue with Cross Linking

    Procedure/Surgery

    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.

  • Corneal Donor Tissue without Cross Linking

    Procedure/Surgery

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Participants Receiving Treated Cross Linked Corneal TissueExperimental treatment 1 intervention
Group B: Participants Receiving Untreated Cross Linked Corneal TissuePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts Eye and Ear Infirmary

Lead sponsor

Source ClinicalTrials.gov
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