ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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 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.