Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure

Last updated: August 19, 2024
Sponsor: University of Missouri-Columbia
Overall Status: Suspended

Phase

2

Condition

Myopia

Eye Disorders/infections

Treatment

Oral Riboflavin

Clinical Study ID

NCT03552016
2011340 HS
  • Ages 6-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism nomore than 1.5 D.

  • Caretakers who choose to enroll their child in the study must agree to participatein the study on their own will after knowledge of potential alternatives (spectaclecorrection, orthokeratology, atropine eye drops, etc.) are explained to thepatient's caretaker.

Exclusion

Exclusion Criteria:

  • Known allergy to riboflavin

  • Birth history of premature birth

  • Developmental delay or other neurological or mental conditions

  • Major systemic health problems

  • Significant anisometropia more than 1.5 Diopters

  • Any other eye condition which may complicate interpretation of data including:congenital glaucoma, congenital cataract, ectatic corneal condition, amblyopia orstrabismus.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Oral Riboflavin
Phase: 2
Study Start date:
October 10, 2018
Estimated Completion Date:
October 10, 2030

Study Description

Myopia is equivalent to the colloquial term known as near-sightedness. This, in short, means that the image of one's environment is projected in front of the retina (rather than directly on the retina, which is ideal). Of course, glasses can be used to correct the image disparity that is created by being near-sighted (that is why a lot of people need glasses for blurry vision). However, glasses and spectacles and contacts do not correct the underlying problem. Most near-sightedness is due to the eye being "too long" and therefore the image projects in front of the retina. Ideally, if we could prevent the eye from becoming abnormally "long", then we could prevent the progression of near-sightedness. Indeed, a child may only be slightly near-sighted early in life, but as he/she continues to perform activities within an arms length of their environment, they can become progressively near-sighted. Besides spectacle correction, people have tried topical atropine drops (medicated eye drops) and rigid contact lenses (orthokeratology) to attempt to correct near-sightedness. Atropine drops take a lot of cooperation from parent and child. Orthokeratology also requires a lot of cooperation, but also, does not permanently stall myopic progression. The investigators suggest a different means of potentially preventing near-sightedness from getting worse (and thus prevent the eye from getting "too long"). The investigators plan on using riboflavin (a Vitamin that can easily be taken orally each day) and having the children involved in the study play outside (where there is UV light created by the sun) in order to prevent the eye from becoming progressively more near-sighted.

Connect with a study center

  • Eye Institute East

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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