Refractive Errors Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 10, 2023 |
Est. primary completion date | October 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Eye Institute East | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cycloplegic refraction | We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group. | 3 years | |
Secondary | Change in axial length | Change in axial length over 3 years in each treatment/study group. | 3 years | |
Secondary | Change in keratometry values | Change in keratometry values over 3 years in each study group. | 3 years | |
Secondary | Change in uncorrected best visual acuity | Change in uncorrected best visual acuity over 3 years in each study group. | 3 years |
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