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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2026-02-02

No results posted yet for this study

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).

Conditions

  • Down Syndrome (DS)
  • Keratoconus
  • Pellucid Marginal Degeneration
  • Forme Fruste Keratoconus (FFK)

Interventions

COMBINATION_PRODUCT

Epi-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.

Sponsors & Collaborators

  • Woolfson Eye Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2028-11-30
Completion
2028-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135167 on ClinicalTrials.gov