Actively Recruiting
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Led by Woolfson Eye Institute · Updated on 2026-02-02
485
Participants Needed
12
Research Sites
178 weeks
Total Duration
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AI-Summary
What this Trial Is About
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred. CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus. The main question it aims to answer is: * Does CXL help prevent or slow the progression of someone's corneal condition and vision loss? Participants will: * Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given. Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light). * There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.
CONDITIONS
Official Title
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 8 years of age or older, any gender or race
- Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, or forme fruste keratoconus based on eye examinations
- Provide written informed consent and signed HIPAA form; subjects under 14 years must also sign assent, and a parent or guardian must consent
- Be willing and able to follow study instructions and attend all follow-up visits
- If female and able to become pregnant, not be pregnant or lactating and agree to use effective birth control from one week before treatment through one month after treatment
You will not qualify if you...
- Normal corneal topography
- History of previous corneal transplant in the study eye
- Minimum corneal thickness less than 300 microns as measured by Pentacam and Ultrasound at screening
- Previous eye conditions other than refractive error that could cause complications or prevent vision improvement, including active or past corneal disease like herpes keratitis
- Significant central corneal scarring that would prevent functional vision even with contact lenses after treatment
- Known allergy or sensitivity to the study treatment or medications
- Nystagmus or any condition preventing steady gaze during treatment or tests
- Female participants who are pregnant, nursing, planning pregnancy, or have a positive pregnancy test before randomization or treatment
- Inability to remove soft or scleral contact lenses at least 3 days before exams
- Inability to remove rigid gas-permeable lenses at least 2 weeks before exams
- Inability to return for required postoperative visits
- Any other condition or finding that makes the participant unsuitable for crosslinking or study participation, as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
Woolfson Eye Institute
Atlanta, Georgia, United States, 30328
Actively Recruiting
2
Woolfson Eye Institute
Atlanta, Georgia, United States, 30349
Actively Recruiting
3
Woolfson Eye Institute
Canton, Georgia, United States, 30114
Actively Recruiting
4
Woolfson Eye Institute
Cumming, Georgia, United States, 30041
Actively Recruiting
5
Woolfson Eye Institute
Douglasville, Georgia, United States, 30134
Actively Recruiting
6
Woolfson Eye Institute
Lawrenceville, Georgia, United States, 30043
Actively Recruiting
7
Woolfson Eye Institute
Marietta, Georgia, United States, 30066
Actively Recruiting
8
Woolfson Eye Institute
Snellville, Georgia, United States, 30078
Actively Recruiting
9
Woolfson Eye Institute
Asheville, North Carolina, United States, 28803
Actively Recruiting
10
Woolfson Eye Institute
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
11
Woolfson Eye Institute
Johnson City, Tennessee, United States, 37615
Actively Recruiting
12
Woolfson Eye Institute
Knoxville, Tennessee, United States, 37922
Actively Recruiting
Research Team
L
LuAnn Bryant
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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