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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      Corneal ectasia as a complication from refractive (LASIK) surgery as well as keratoconus is a
      slowly progressive condition that results in high patient morbidity. Treatment options aim to
      stabilize the shape of the cornea using rigid contact lenses, surgical insertion of stiff
      plastic intrastromal rings, corneal cross linking, and ultimately corneal transplant in
      severe patients. The recently FDA approved "Dresden Protocol" involves painful cornea
      scraping followed by application of concentrated Riboflavin, followed by immediate collagen
      cross linking with UV light exposure which results in shortening and thickening of the
      collagen fibrils, and therefore a stronger, stiffer cornea. Avedro has demonstrated an
      average cornea flattening (K max reduction) of 1.4 diopters and 1.7diopters in two different
      studies. The current cost of Avedro therapy is between $2500 -$3500 per treatment. This is
      considered experimental at this time and therefore is not covered by any insurance.To spare
      the patient the severe pain involved in the current procedure, and to avoid the high cost
      (Avedro is not covered by any medical insurance), the investigator started 7 patients with
      keratoconus from 2011-2015 in his private practice in Seattle on a trial of oral riboflavin
      (100 mg or 400 mg daily) and 15 minutes of sunlight exposure daily. No adverse effects have
      ever been reported with high-dose dietary riboflavin supplements. The results of this
      preliminary trial are remarkable. During follow-up from 6 months to 5 years, all 7 patients
      have had corneal stabilization and/or corneal flattening. One patient experienced flattening
      of the cornea by 1.5 Diopters, comparable to the best results of the Avedro system. A limited
      animal study is currently underway to document that corneal cross-linking occurs in response
      to dietary riboflavin and UV exposure from the sun. This clinical study would expand the
      promising preliminary findings to a larger sample size. 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.
    


Study Type

Interventional


Primary Outcome

Degree of corneal steepening

Secondary Outcome

 Best corrected visual acuity

Condition

Keratoconus

Intervention

Dietary riboflavin

Study Arms / Comparison Groups

 Treatment with riboflavin
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

24

Start Date

May 1, 2017

Completion Date

January 2022

Primary Completion Date

January 2022

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          -  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
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

John S Jarstad, MD, (573) 884-2876, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03095235

Organization ID

2006390


Responsible Party

Principal Investigator

Study Sponsor

University of Missouri-Columbia


Study Sponsor

John S Jarstad, MD, Principal Investigator, University of Missouri- Department of Ophthalmology


Verification Date

April 2019