RECRUITING

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

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Conditions

Corneal Transplant FailureKeratoplastyCross Linking

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2031-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06753916

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 and older
  2. * Willing and able to provide written informed consent
  3. * Willing and able to comply with study assessments for the full duration of the study
  4. * 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
  5. * 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).
  1. * History of Stevens-Johnson syndrome or ocular pemphigoid
  2. * Ocular or periocular malignancy
  3. * Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
  4. * Uncontrolled glaucoma
  5. * Change in topical corticosteroid regimen within 14 days of transplantation
  6. * Use of systemic immunosuppressive for indication other than corneal graft rejection
  7. * Participation in another simultaneous medical investigation or trial
  8. * Pregnancy (positive pregnancy test) or lactating
  9. * Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
  10. * Ocular infection within 30 days prior to study entry.
  11. * Presence of anterior chamber intraocular lens
  12. * Active uveitis within 90 days prior to the study entry.
  13. * No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.

Contacts and Locations

Study Contact

Michael Cheung, MSc, CCRP
CONTACT
6175736060
mcheung0@meei.harvard.edu
Nikolay Boychev, OD, PhD
CONTACT

Principal Investigator

Joseph Ciolino, MD
PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear

Study Locations (Sites)

University of California Irvine - Gavin Herbert Eye Institute
Irvine, California, 92617
United States
The University of California Los Angeles - Doris Stein Eye Research Center
Los Angeles, California, 90095
United States
University of California San Francisco - Wayne and Gladys Valley Center for Vision
San Francisco, California, 94158
United States
University of Miami - Bascom Palmer Eye Institute
Miami, Florida, 33136
United States
Price Vision Group
Indianapolis, Indiana, 46260
United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
United States
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, 48015
United States
Wake Forest Baptist Eye Center
Bermuda Run, North Carolina, 27006
United States
Duke University - Duke Eye Center
Durham, North Carolina, 27705
United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

  • Joseph Ciolino, MD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2031-01-01

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2031-01-01

Terms related to this study

Keywords Provided by Researchers

  • Keratoplasty
  • Cross Linking

Additional Relevant MeSH Terms

  • Corneal Transplant Failure