Virginia Commonwealth University
Richmond, Virginia, 23298, United States
NCT Number: NCT03552016
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.
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Notify Me6 year–12 year
All sexes
Interventional
Phase 2
Richmond, Virginia, 23298, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 3 years
We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.
Time frame: 3 years
Change in axial length over 3 years in each treatment/study group.
Time frame: 3 years
Change in keratometry values over 3 years in each study group.
Time frame: 3 years
Change in uncorrected best visual acuity over 3 years in each study group.
University of Missouri-Columbia
Other
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