Actively Recruiting
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Using UVA Exposure for Eyes with Ectatic Corneal Diseases in Subjects with Down Syndrome
Led by Woolfson Eye Institute · Updated on 2026-02-02
225
Participants Needed
12
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental treatment called corneal crosslinking (CXL) for people with Down syndrome who have corneal conditions where the cornea thins, steepens, and becomes misshapen, causing blurred vision. This treatment aims to strengthen the cornea and possibly prevent or slow vision loss. The study focuses on whether CXL can stop or slow this progression. Participants must be at least 8 years old and diagnosed with Down syndrome or similar cognitive or developmental conditions. The treatment involves applying riboflavin (Vitamin B2) eye drops to the eye, followed by exposure to ultraviolet A (UVA) light for 20 minutes. This process is called Epi-ON corneal cross-linking and is performed during the study. Participants will receive this treatment and be monitored over a 6-month period. Participants will attend up to 7 in-office visits during the 6 months, where various eye and vision tests will be conducted. Researchers will measure corneal curvature and vision changes using tools like the Pentacam and visual acuity tests. They will also assess vision improvements with additional measures such as high order aberrations and coma. The study includes follow-up visits to track treatment effects and safety over time.
CONDITIONS
Brief 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 old, any gender, any race
- Have a diagnosis of Down syndrome or a cognitive, developmental, or medical condition affecting ability to follow instructions
- Diagnosed with keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL, other ectatic condition, or forme fruste keratoconus
- Provide written informed consent and HIPAA form; subjects under 14 must assent with parent/guardian consent
- Successfully complete clinical evaluation for suitability for CXL
- Willing and able to follow instructions and comply with follow-up schedules
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 ocular conditions that could cause complications or prevent vision improvement, such as herpes simplex or significant corneal scarring
- Known allergy or sensitivity to the study treatment or its components
- Nystagmus or conditions preventing steady gaze during treatment or tests
- Female participants who are pregnant, lactating, planning pregnancy, or positive pregnancy test
- Inability to remove soft or scleral contact lenses 3 days before exams
- Inability to remove rigid gas-permeable contact lenses 2 weeks before exams
- Inability to attend required postoperative exams
- Any other condition making the participant unsuitable for CXL or study participation as judged by the investigator
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.
1 visit (in-person)
Duration - Up to 6 months
Participants receive Epi-ON corneal cross-linking involving riboflavin eye drops followed by 20 minutes of UVA light exposure to treat ectatic corneal diseases.
Initial treatment visit with follow-up visits during treatment as scheduled
Duration - Up to 6 months post-treatment
Participants are monitored for vision improvement and corneal curvature changes after treatment.
Follow-up visits to assess vision and corneal health
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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