Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposu
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 riboflav
| Condition(s) | Keratoconus, Ectasia of Cornea, Pellucid Marginal Corneal Degeneration, Forme Fruste Keratoconus (FFK) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study: 1. Be at least 8 years of age or older, male or female, of any race. 2. Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus based on topography, tomography, and slit lamp examination. 3. Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. 4. Be willing and able to follow all instructions and comply with the schedule for follow-up visits. 5. If female and capable of becoming pregnant, must not be lact |
| Ages | 8 Years |
| Sex | All |
| Lead sponsor | Woolfson Eye Institute |
| Locations | Atlanta, Georgia, United States; Atlanta, Georgia, United States; Canton, Georgia, United States; Cumming, Georgia, United States; Douglasville, Georgia, United States; Lawrenceville, Georgia, United States (+6 more sites) |
| Start date | 2025-08-01 |
| NCT ID | NCT07124910 |
| Official listing | https://clinicaltrials.gov/study/NCT07124910 |