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
Recruiting
Phase 3
Interventional Study
Keratoconus
Ectasia of Cornea
Pellucid Marginal Corneal Degeneration
Forme Fruste Keratoconus (FFK)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 8 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 485 (estimated)
- Sponsor
- Woolfson Eye Institute · Other
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About This Trial
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) li…
Trial Locations
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Eligibility Criteria
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 de…
Contacts