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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
No Placebo-Only Group
Summary
This trial tests if taking vitamin B2 pills and spending time in the sun can help strengthen the cornea in patients with certain eye conditions. The goal is to provide a less painful and cheaper alternative to current treatments. A method using vitamin B2 and sunlight has been developed since the late 1990s to strengthen the cornea in these conditions.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Degree of corneal steepening
Secondary study objectives
Best corrected visual acuity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Keratoconus treatments primarily aim to stabilize the cornea and prevent further progression of the disease. One common treatment is corneal cross-linking, which involves the application of riboflavin (vitamin B2) to the cornea followed by exposure to ultraviolet (UV) light.
This process strengthens the corneal tissue by forming new chemical bonds between collagen fibers, thereby increasing the cornea's rigidity and stability. The trial involving oral riboflavin and natural sunlight exposure hypothesizes a similar mechanism, where riboflavin activated by natural UV light could induce corneal cross-linking.
This is significant for Keratoconus patients as it offers a non-invasive, potentially cost-effective method to halt disease progression and reduce the need for more invasive procedures like corneal transplants.
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,588 Total Patients Enrolled
University of South FloridaOTHER
427 Previous Clinical Trials
192,607 Total Patients Enrolled
John S Jarstad, MDPrincipal InvestigatorUniversity of South Florida - Department of Ophthalmology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or sensitive to riboflavin.You have a known sensitivity to sunlight.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment with riboflavin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.