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Vitamin

Riboflavin for Keratoconus

N/A
Recruiting
Led By John S Jarstad, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing whether a daily dose of riboflavin and exposure to natural sunlight is as effective in treating corneal ectasia as the current FDA-approved therapy. If the trial is successful, it could save millions of dollars in healthcare costs.

Who is the study for?
This trial is for individuals with keratoconus or post-refractive cornea ectasia and significant astigmatism. It's not suitable for those sensitive to sunlight or riboflavin, or on medications that increase sunlight sensitivity unless cleared by their doctor.Check my eligibility
What is being tested?
The study tests if dietary riboflavin (Vitamin B-2) combined with natural sunlight exposure can strengthen the cornea similarly to FDA-approved Avedro therapy, potentially offering a less expensive treatment option.See study design
What are the potential side effects?
So far, patients have reported no adverse effects from oral riboflavin and daily sun exposure. However, potential side effects could include issues related to increased sun sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degree of corneal steepening
Secondary outcome measures
Best corrected visual acuity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with riboflavinExperimental Treatment1 Intervention
Patients will take 400 mg dietary riboflavin per day and go outside without sunglasses for 15 minutes per day to evaluate the effects of riboflavin B2 and natural UV light from sun exposure on cornea cross linking and stabilization of ectatic disease.

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,970 Total Patients Enrolled
University of South FloridaOTHER
407 Previous Clinical Trials
186,785 Total Patients Enrolled
John S Jarstad, MDPrincipal InvestigatorUniversity of South Florida - Department of Ophthalmology

Media Library

Dietary Riboflavin (Vitamin B-2) (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT03095235 — N/A
Keratoconus Research Study Groups: Treatment with riboflavin
Keratoconus Clinical Trial 2023: Dietary Riboflavin (Vitamin B-2) Highlights & Side Effects. Trial Name: NCT03095235 — N/A
Dietary Riboflavin (Vitamin B-2) (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03095235 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this trial in terms of participant numbers?

"Affirmative. The records hosted on clinicaltrials.gov verify that this medical trial, which was first listed in May 1st 2017, is still actively recruiting participants. Specifically, 24 people are needed from two separate locations for the study to proceed."

Answered by AI

Are there any opportunities for patients to join this clinical investigation at present?

"Clinicaltrials.gov affirms that, as of 7/26/2023, this medical trial is still searching for suitable patients to enrol in their study. The initial posting date was 5/1/2017"

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
University of Missouri
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long do screening visits take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking
John Jarstad, M.D. 2017. "Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03095235.
~3 spots leftby Apr 2025
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