RECRUITING

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

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.

Conditions

Corneal Transplant Failure
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Related Conditions:

Corneal Transplant Failure

Study Overview

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Study Details

Study overview

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.

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

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Condition
Corneal Transplant Failure
Intervention / Treatment

-

Contacts and Locations

Irvine

University of California Irvine - Gavin Herbert Eye Institute, Irvine, California, United States, 92617

Los Angeles

The University of California Los Angeles - Doris Stein Eye Research Center, Los Angeles, California, United States, 90095

San Francisco

University of California San Francisco - Wayne and Gladys Valley Center for Vision, San Francisco, California, United States, 94158

Miami

University of Miami - Bascom Palmer Eye Institute, Miami, Florida, United States, 33136

Indianapolis

Price Vision Group, Indianapolis, Indiana, United States, 46260

Boston

Massachusetts Eye and Ear, Boston, Massachusetts, United States, 02114

Ann Arbor

University of Michigan - Kellogg Eye Center, Ann Arbor, Michigan, United States, 48015

Bermuda Run

Wake Forest Baptist Eye Center, Bermuda Run, North Carolina, United States, 27006

Durham

Duke University - Duke Eye Center, Durham, North Carolina, United States, 27705

Cincinnati

Cincinnati Eye Institute, Cincinnati, Ohio, United States, 45242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts Eye and Ear Infirmary,

Joseph Ciolino, MD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

2031-01-01