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

Phase 2

Waitlist Available

Led By Mohannad Al-Samarraie, MD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial aims to prevent children from becoming more near-sighted by giving them a vitamin and encouraging outdoor play in sunlight. The combination of the vitamin and UV light may help stop the eye from growing too long, which causes near-sightedness.

Eligible Conditions

Refractive Errors
Nearsightedness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in cycloplegic refraction

Secondary study objectives

Change in axial length

Change in keratometry values

Change in uncorrected best visual acuity

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 400 mg Riboflavin (oral)Experimental Treatment1 Intervention

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.

Group II: 200 mg Riboflavin (oral)Experimental Treatment1 Intervention

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.

Group III: 0 mg Riboflavin (oral)Placebo Group1 Intervention

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.

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