Actively Recruiting
ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-04-21
96
Participants Needed
12
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 in 1 or more quadrants 2 mm from the limbus or extension of corneal neovascularization to the graft-host junction in a previously failed graft
- Superficial vessels defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea
- Classification of corneal neovascularization severity based on extent and depth of vessels
You will not qualify if you...
- History of Stevens-Johnson syndrome or ocular pemphigoid
- Presence of ocular or periocular malignancy
- Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting 6 weeks or more preoperatively
- Uncontrolled glaucoma
- Change in topical corticosteroid regimen within 14 days of transplantation
- Use of systemic immunosuppressive drugs for reasons other than corneal graft rejection
- Participation in another simultaneous medical trial
- Pregnancy or lactating
- Pre-menopausal women not using reliable contraception
- Ocular infection within 30 days prior to study entry
- Presence of anterior chamber intraocular lens
- Active uveitis within 90 days prior to study entry
- No ocular surgery or procedure within 90 days prior to or concomitant with study procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of California Irvine - Gavin Herbert Eye Institute
Irvine, California, United States, 92617
Not Yet Recruiting
2
The University of California Los Angeles - Doris Stein Eye Research Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of California San Francisco - Wayne and Gladys Valley Center for Vision
San Francisco, California, United States, 94158
Not Yet Recruiting
4
University of Miami - Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
5
Price Vision Group
Indianapolis, Indiana, United States, 46260
Actively Recruiting
6
Kansas City Eye Clinic
Overland Park, Kansas, United States, 66204
Actively Recruiting
7
Mid-Atlantic Cornea Consultant
Towson, Maryland, United States, 21204
Not Yet Recruiting
8
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, United States, 48015
Actively Recruiting
10
Wake Forest Baptist Eye Center
Bermuda Run, North Carolina, United States, 27006
Not Yet Recruiting
11
Duke University - Duke Eye Center
Durham, North Carolina, United States, 27705
Actively Recruiting
12
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
Actively Recruiting
Research Team
M
Michael Cheung, MSc, CCRP
CONTACT
N
Nikolay Boychev, OD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here