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

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03552016
• Other study ID #: 2011340 HS
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2018
• Est. completion date: October 10, 2023

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: Mohannad Al-Samarraie, MD
• Phone: 573-882-1506
• Email: alsamarraiem[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Axial Myopia
• Myopia
• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
United States	Eye Institute East	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

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