Actively Recruiting
Comparison of Epi-ON Corneal Collagen Crosslinking Using 18-Minute vs 24-Minute UVA Exposure in Eyes with Ectatic Corneal Diseases
Led by Woolfson Eye Institute · Updated on 2026-02-02
485
Participants Needed
12
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies the effects of a new treatment called corneal crosslinking (CXL) for eye conditions where the cornea becomes thin, steep, and misshapen, causing blurry vision. The trial focuses on patients aged 8 years and older diagnosed with keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus. The main goal is to find out if CXL can slow or stop the progression of these corneal diseases and prevent vision loss. Participants will receive CXL treatment where riboflavin (Vitamin B2 eye drops) is applied to the eye, followed by exposure to ultraviolet A (UVA) light. Two groups will be compared: one group receives UVA treatment for 18 minutes and the other for 24 minutes, both with 15-second off-on cycling. The treatment aims to strengthen the cornea and stop disease progression. During the 6-month study, participants will attend up to 7 office visits for eye and vision tests. Researchers will measure corneal curvature using Kmax with the Pentacam and corrected distance visual acuity (CDVA) to evaluate effectiveness. Secondary measures include uncorrected visual acuity (UCVA) and possibly changes in higher order aberrations (HOA) and coma if wavefront testing is done. Safety and treatment effects will be monitored throughout the study period.
CONDITIONS
Brief 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
- Diagnosis of keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus confirmed by eye exams
- Provide written informed consent and HIPAA form; subjects under 14 must also provide assent with parental consent
- Willing and able to follow instructions and attend all follow-up visits
- If female and able to become pregnant, not pregnant or nursing and agree to use birth control for one week before and one month after treatment
You will not qualify if you...
- Normal corneal topography
- History of corneal transplant in the study eye
- Corneal thickness less than 300 microns at screening
- Previous eye conditions likely to cause complications or prevent vision improvement, including active or past corneal infections or significant central scarring
- Known allergy or sensitivity to the study treatment or medications
- Nystagmus or any condition preventing steady gaze during treatment or tests
- Pregnant, nursing, or planning pregnancy during the study
- Inability to remove soft or scleral contact lenses at least 3 days before visits
- Inability to remove rigid gas-permeable contact lenses at least 2 weeks before visits
- Unable to return for required follow-up exams
- Any condition judged by the investigator to make participation unsuitable or to interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants receive Epi-ON corneal collagen cross-linking with either 18-minute or 24-minute UVA exposure.
1 treatment visit followed by multiple follow-up visits over 6 months
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
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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