TERMINATED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-05-01
Study Completion:2021-03-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT03095235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * patients identified as having keratoconus or post refractive cornea ectasia with astigmatism of 1.5 Diopters or greater.
  1. * Known sensitivity to riboflavin, sunlight.
  2. * patients on medications with side effects of increased sunlight sensitivity should discuss participation with their prescribing provider prior to participation

Contacts and Locations

Principal Investigator

John S Jarstad, MD
PRINCIPAL_INVESTIGATOR
University of South Florida - Department of Ophthalmology

Study Locations (Sites)

University of South Florida Department of Ophthalmology
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • John S Jarstad, MD, PRINCIPAL_INVESTIGATOR, University of South Florida - Department of Ophthalmology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-05-01
Study Completion Date2021-03-08

Study Record Updates

Study Start Date2017-05-01
Study Completion Date2021-03-08

Terms related to this study

Keywords Provided by Researchers

  • keratoconus
  • cornea ectasia

Additional Relevant MeSH Terms

  • Keratoconus
  • Cornea Ectasia