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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
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
Conditions
Interventions
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