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NCT Number: NCT03552016

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

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.

Why the study stopped: Lack of funds and move of all investigators to other institutions.
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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
  • Caretakers who choose to enroll their child in the study must agree to participate in the study on their own will after knowledge of potential alternatives (spectacle correction, orthokeratology, atropine eye drops, etc.) are explained to the patient's caretaker.

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 or strabismus.

Treatment and study plan

Oral Riboflavin

Drug

The intervention doses will be 200 mg oral riboflavin and 400 mg oral riboflavin doses; the placebo dose will be 0 mg of oral riboflavin

Other names: Vitamin B2

Primary outcomes

  1. Change in cycloplegic refraction

    Time frame: 3 years

    We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.

Secondary outcomes

  1. Change in axial length

    Time frame: 3 years

    Change in axial length over 3 years in each treatment/study group.

  2. Change in keratometry values

    Time frame: 3 years

    Change in keratometry values over 3 years in each study group.

  3. Change in uncorrected best visual acuity

    Time frame: 3 years

    Change in uncorrected best visual acuity over 3 years in each study group.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2018
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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