Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome (NCT07135167)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Woolfson Eye Institute — Atlanta, Georgia
Age range: 8 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- Woolfson Eye Institute — Atlanta, Georgia
- Woolfson Eye Institute — Atlanta, Georgia
- Woolfson Eye Institute — Canton, Georgia
- Woolfson Eye Institute — Cumming, Georgia
- Woolfson Eye Institute — Douglasville, Georgia
- Woolfson Eye Institute — Lawrenceville, Georgia
- Woolfson Eye Institute — Marietta, Georgia
- Woolfson Eye Institute — Snellville, Georgia
- Woolfson Eye Institute — Asheville, North Carolina
- Woolfson Eye Institute — Chattanooga, Tennessee
- Woolfson Eye Institute — Johnson City, Tennessee
- Woolfson Eye Institute — Knoxville, Tennessee
📞 Contact the Study Coordinator
Phone: (770) 804-1684
Email: lbryant@woolfsoneye.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Down Syndrome (DS) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.