Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 200 mg Riboflavin (oral) These patients (approximately 1/3rd of all patients enrolled in the study) will be given 200 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
Drug: Oral Riboflavin
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:
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Experimental: 400 mg Riboflavin (oral) These patients (approximately 1/3rd of all patients enrolled in the study) will be given 400 mg oral riboflavin each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
Drug: Oral Riboflavin
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:
|
Placebo Comparator: 0 mg Riboflavin (oral) These patients (approximately 1/3rd of all patients enrolled in the study) will be given 0 mg oral riboflavin (placebo) each day for 6 months and be encouraged to play outside for 30 minutes a day every day. |
Drug: Oral Riboflavin
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:
|
Outcome Measures
Primary Outcome Measures
- Change in cycloplegic refraction [3 years]
We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.
Secondary Outcome Measures
- Change in axial length [3 years]
Change in axial length over 3 years in each treatment/study group.
- Change in keratometry values [3 years]
Change in keratometry values over 3 years in each study group.
- Change in uncorrected best visual acuity [3 years]
Change in uncorrected best visual acuity over 3 years in each study group.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy children ages 6-12 years old with myopia more than 0.50 D and astigmatism no more than 1.5 D.
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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:
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Known allergy to riboflavin
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Birth history of premature birth
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Developmental delay or other neurological or mental conditions
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Major systemic health problems
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Significant anisometropia more than 1.5 Diopters
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Any other eye condition which may complicate interpretation of data including: congenital glaucoma, congenital cataract, ectatic corneal condition, amblyopia or strabismus.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Eye Institute East | Columbia | Missouri | United States | 65201 |
Sponsors and Collaborators
- University of Missouri-Columbia
Investigators
- Principal Investigator: Mohannad Al-Samarraie, MD, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2011340 HS