Actively Recruiting
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Led by Woolfson Eye Institute · Updated on 2026-02-02
225
Participants Needed
12
Research Sites
178 weeks
Total Duration
On this page
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 8 years of age or older and have a diagnosis of Down syndrome. 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 for 20 minutes).
CONDITIONS
Official Title
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
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 Down syndrome or other cognitive, developmental, or medical conditions affecting ability to follow instructions
- Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL, other ectatic condition, or forme fruste keratoconus confirmed by eye examinations
- Provide written informed consent; pediatric subjects under 14 must assent and have parent/guardian consent; if unable to consent, legally authorized representative must sign
- Complete a clinical evaluation confirming suitability for corneal crosslinking
- Willing and able to comply with instructions and follow-up visit schedule
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 (besides refractive error) that increase risk or prevent vision improvement, including active or past corneal disease like herpes keratitis
- Significant central corneal scarring preventing functional vision after treatment
- Known allergy or sensitivity to the treatment or its components
- Nystagmus or other conditions preventing steady gaze during treatment or tests
- For females, pregnancy, breastfeeding, planning pregnancy, or positive pregnancy test before treatment; must use birth control starting one week before treatment and for one month after
- Inability to remove soft or scleral contact lenses at least 3 days before exams
- Inability to remove rigid gas-permeable contact lenses at least 2 weeks before exams
- Unable to return for required postoperative examinations
- Any other condition deemed by investigators to make the participant unsuitable or to affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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