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RECRUITING
NCT07124910
PHASE3

Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases

Sponsor: Woolfson Eye Institute

View on ClinicalTrials.gov

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 at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus. 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). * There will be two groups of participants. One group will receive the UVA treatment for 18 minutes and the other group will receive the UVA treatment for 24 minutes.

Official title: Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure Versus a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases

Key Details

Gender

All

Age Range

8 Years - Any

Study Type

INTERVENTIONAL

Enrollment

485

Start Date

2025-08-01

Completion Date

2028-12-31

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Epi-ON corneal cross-linking

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

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