What side effects are associated with this type of intervention?

Common treatments for keratoconus include riboflavin-induced corneal cross-linking, rigid contact lenses, and corneal implants. Riboflavin-induced corneal cross-linking, which involves the application of riboflavin (vitamin B2) followed by UV light exposure, can cause side effects such as eye pain, corneal haze, and temporary vision disturbances. Rigid contact lenses may lead to discomfort, lens intolerance, and corneal abrasions. Corneal implants can result in complications like infection, implant extrusion, and vision fluctuations. The trial studying oral riboflavin and natural sunlight exposure aims to offer a less invasive alternative with potentially fewer side effects.

What prior FDA approvals exist?

The FDA has approved the Avedro therapy for the treatment of keratoconus, which involves a riboflavin (vitamin B2) solution applied to the cornea followed by ultraviolet (UV) light exposure. This procedure, known as corneal collagen cross-linking, strengthens the cornea by forming new bonds between collagen fibers, helping to stabilize its shape and prevent further deterioration. This is similar to the treatment being studied in the trial involving oral riboflavin and natural sunlight exposure.

What other types of research exist?

Promising novel alternatives for keratoconus treatment in 2024 include the use of advanced riboflavin formulations combined with UV light therapy, which is FDA-approved and has shown efficacy in corneal stabilization. Additionally, the development of new biomaterials for intrastromal corneal ring segments and advancements in corneal transplantation techniques offer potential improvements in treatment outcomes. Ongoing research into gene therapy and regenerative medicine may also provide future therapeutic options.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

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.

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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.

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Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

376 Previous Clinical Trials

628,637 Total Patients Enrolled

University of South FloridaOTHER

422 Previous Clinical Trials

189,203 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

~2 spots leftby Jun 2025

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