RecruitingPhase 3NCT07135167

Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome


Sponsor

Woolfson Eye Institute

Enrollment

225 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 8 Years

Plain Language Summary

Simplified for easier understanding

This compassionate use trial provides corneal crosslinking (CXL) — a treatment that uses riboflavin (vitamin B2) eye drops followed by 20 minutes of ultraviolet A light — to people with Down syndrome or similar developmental conditions who have a progressive corneal disease called keratoconus or a related ectatic disorder, which causes the cornea to thin and distort, blurring vision. CXL is designed to halt disease progression by stiffening the cornea, and this study focuses on individuals who may have difficulty tolerating standard clinical procedures or informed consent processes. Participants must be aged 8 or older, have a confirmed diagnosis of Down syndrome (or a comparable condition), and have a progressive corneal disorder confirmed by imaging; a parent or legal guardian must provide consent. Participation involves up to 7 clinic visits over 6 months, including eye and vision tests before and after the CXL procedure. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTEpi-ON corneal cross-linking (CXL)

Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light for 20 minutes.


Locations(12)

Woolfson Eye Institute

Atlanta, Georgia, United States

Woolfson Eye Institute

Atlanta, Georgia, United States

Woolfson Eye Institute

Canton, Georgia, United States

Woolfson Eye Institute

Cumming, Georgia, United States

Woolfson Eye Institute

Douglasville, Georgia, United States

Woolfson Eye Institute

Lawrenceville, Georgia, United States

Woolfson Eye Institute

Marietta, Georgia, United States

Woolfson Eye Institute

Snellville, Georgia, United States

Woolfson Eye Institute

Asheville, North Carolina, United States

Woolfson Eye Institute

Chattanooga, Tennessee, United States

Woolfson Eye Institute

Johnson City, Tennessee, United States

Woolfson Eye Institute

Knoxville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07135167


Related Trials