Columbia, Missouri 65201

  • Refractive Errors

Purpose:

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 summary:

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.


Criteria:

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.


NCT ID:

NCT03552016


Primary Contact:

Principal Investigator
Mohannad Al-Samarraie, MD
University of Missouri-Columbia

Mohannad Al-Samarraie, MD
Phone: 573-882-1506
Email: alsamarraiem@health.missouri.edu


Backup Contact:

Email: mercerr@health.missouri.edu
Ryan N Mercer, MD
Phone: 803-740-9673


Location Contact:

Columbia, Missouri 65201
United States

Mohannad Al-Samarraie, MD
Phone: 573-882-7389
Email: alsamarraiem@health.missouri.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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