Using dietary riboflavin to treat corneal ectasia and keratoconus
Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking
This study is testing whether taking high doses of riboflavin, along with getting daily sunlight, can help people with corneal ectasia and keratoconus improve their vision and stabilize their cornea without painful procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT03095235 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of dietary riboflavin (Vitamin B-2) as a treatment for corneal ectasia and keratoconus, conditions characterized by corneal irregularity and thinning. The approach involves administering high doses of riboflavin orally, combined with daily sunlight exposure, as an alternative to the painful and costly collagen cross-linking procedure. The goal is to stabilize the cornea's shape and improve visual acuity without the adverse effects associated with traditional treatments. The study aims to evaluate the effectiveness and safety of this novel treatment method.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with keratoconus or post-refractive corneal ectasia who have astigmatism of 1.5 diopters or greater.
Not a fit: Patients with known sensitivity to riboflavin or sunlight, as well as those on medications that increase sunlight sensitivity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less painful and more affordable option for patients suffering from keratoconus and corneal ectasia.
How similar studies have performed: While traditional collagen cross-linking has shown success, the use of dietary riboflavin in this manner is a novel approach that has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients identified as having keratoconus or post refractive cornea ectasia with astigmatism of 1.5 Diopters or greater. Exclusion Criteria: * Known sensitivity to riboflavin, sunlight. * patients on medications with side effects of increased sunlight sensitivity should discuss participation with their prescribing provider prior to participation
Where this trial is running
Tampa, Florida
- University of South Florida Department of Ophthalmology — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: John S Jarstad, MD — University of South Florida - Department of Ophthalmology
- Study coordinator: John S Jarstad, MD
- Email: jarstadj@usf.edu
- Phone: 813-821-8022
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.