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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03552016
Other study ID # 2011340 HS
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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