Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking for Ectatic Corneal Diseases in Down Syndrome
This study is looking at an experimental treatment called Epi-ON corneal collagen cross-linking (CXL) for people with Down Syndrome who have conditions like keratoconus, where the cornea (the clear front part of your eye) becomes thin and misshapen, causing blurry vision. CXL involves putting riboflavin (Vitamin B2 eye drops) into the eye and then exposing it to ultraviolet (UV-A) light. The goal is to strengthen the cornea and stop the disease from getting worse. The study will measure changes in your eye's shape and your vision over 6 months to see if CXL helps prevent or slow vision loss. You can join if you are at least 8 years old and have Down Syndrome or similar conditions.
- Study design
- This is an interventional study planning to enroll 225 participants. The study is testing a treatment called Epi-ON corneal cross-linking.
- What's involved
- You would receive riboflavin eye drops and UV-A light exposure. Your corneal curvature and vision will be measured from enrollment to 6 months after treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your corneal curvature and vision will be measured up to 6 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
At a glance
Conditions
Where it's being run
12 sites across 3 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes.From enrollment to the end of treatment at 6 months.
Primarily using measurements to assess improvement of vision.
- Improvement of vision as assessed by corrected distance visual acuity (CDVA).From enrollment to the end of treatment at 6 months.
Change in CDVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.