Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Public ClinicalTrials.gov record NCT07135167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07135167
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 8 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 1, 2025 (Actual)
- Primary completion
- Nov 2028 (Estimated)
- Completion
- Dec 31, 2028 (Estimated)
- Last update posted
- Feb 2, 2026
2025 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 3
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Woolfson Eye Institute | Atlanta | Georgia | 30328 | Recruiting |
| Woolfson Eye Institute | Atlanta | Georgia | 30349 | Recruiting |
| Woolfson Eye Institute | Canton | Georgia | 30114 | Recruiting |
| Woolfson Eye Institute | Cumming | Georgia | 30041 | Recruiting |
| Woolfson Eye Institute | Douglasville | Georgia | 30134 | Recruiting |
| Woolfson Eye Institute | Lawrenceville | Georgia | 30043 | Recruiting |
| Woolfson Eye Institute | Marietta | Georgia | 30066 | Recruiting |
| Woolfson Eye Institute | Snellville | Georgia | 30078 | Recruiting |
| Woolfson Eye Institute | Asheville | North Carolina | 28803 | Recruiting |
| Woolfson Eye Institute | Chattanooga | Tennessee | 37421 | Recruiting |
| Woolfson Eye Institute | Johnson City | Tennessee | 37615 | Recruiting |
| Woolfson Eye Institute | Knoxville | Tennessee | 37922 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07135167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07135167 live on ClinicalTrials.gov.