Dietary Riboflavin (Vitamin B-2) and Cornea Cross-Linking

NCT03095235 | Terminated

• 1 other identifier: 2006390
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Corneal ectasia is characterized by irregularity and thinning of the cornea, causing the cornea to bulge forward and cause distorted vision and impaired visual acuity. Corneal ectasia is a complication after refractive (LASIK) surgery. It is also the primary problem in keratoconus, a gradually progressive inherited condition that typically is manifested in young adulthood, more commonly in women. Treatment approaches to stabilize the cornea's shape include rigid contact lenses, surgical implantation of stiff plastic intrastromal corneal ring segments, a collagen cross-linking procedure and, in severe cases, cornea transplantation. The collagen cross-linking procedure involves topical application of a concentrated riboflavin (vitamin B2) solution after the corneal epithelium is scraped, followed by ultraviolet (UV) light exposure. UV light stimulates riboflavin to form new bonds (cross links) between the cornea's connective tissue, giving the cornea additional strength to maintain its shape and prevent the need for transplantation. The cost of one treatment using this system is $2,500 to $3,500. A small prospective study including 7 patients with keratoconus was started on a trial of oral riboflavin and 15 minutes of natural sunlight exposure daily. These patients reported no adverse effects and preliminary results showed corneal stabilization and/or corneal flattening in all 7 patients It is hypothesized that dietary riboflavin and natural sunlight is as effective in corneal crosslinking as the currently FDA approved Avedro therapy. If the clinical study confirms the investigators' early observations of the benefits of this approach, coupled with animal studies that document corneal cross-linking, the investigators will have data to pursue funding for larger clinical and animal studies. This has the potential to save millions of dollars in health care costs and ease the burden of treatment in patients who require therapy to induce corneal cross-linking to stabilize the cornea's shape.

Conditions

Keratoconus; Cornea Ectasia

Keywords

keratoconus; cornea ectasia

Outcome Measures

Primary Outcomes (1)

• Degree of corneal steepening

  Keratometry measures the degree of astigmatism of the cornea to monitor the degree of cornea steepening

  6 months

Secondary Outcomes (1)

• Best corrected visual acuity

  6 months

Study Arms (1)

Treatment with riboflavin

EXPERIMENTAL

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.

Dietary Supplement: Dietary riboflavin

Interventions

Dietary riboflavin DIETARY_SUPPLEMENT

Dietary riboflavin is vitamin B2. It has been shown to be safe in children in the treatment of migraines at doses of 400 mg per day. There are no known documented side effects

Also known as: Vitamin B2

Treatment with riboflavin

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients identified as having keratoconus or post refractive cornea ectasia with astigmatism of 1.5 Diopters or greater.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• University of South Florida: collaborator

Study Sites (1)

University of South Florida Department of Ophthalmology

Tampa, Florida, 33612, United States

Location

Related Publications (3)

• Jarstad JS.Mega-dose DIetary Riboflavin in the Treatment of Keratoconus, Post-Refractive Cornea Ectasia and Migraine. Has its Time Arrived? Archives of Clinical Ophthalmology 2021:1(1):20

  BACKGROUND

• Wu D, Lim DK, Lim BXH, Wong N, Hafezi F, Manotosh R, Lim CHL. Corneal Cross-Linking: The Evolution of Treatment for Corneal Diseases. Front Pharmacol. 2021 Jul 19;12:686630. doi: 10.3389/fphar.2021.686630. eCollection 2021.

  PMID: 34349648 BACKGROUND

• Torres-Netto EA, Abdshahzadeh H, Lu NJ, Kling S, Abrishamchi R, Hillen M, Hafezi NL, Koppen C, Hafezi F. Corneal crosslinking with riboflavin using sunlight. J Cataract Refract Surg. 2023 Oct 1;49(10):1049-1055. doi: 10.1097/j.jcrs.0000000000001241.

  PMID: 37343287 RESULT

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• John S Jarstad, MD

  University of South Florida - Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: March 29, 2017
• Study Start: May 1, 2017
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)