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

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ClinicalTrials.gov Identifier: NCT03552016
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Mohanned Al-Samarraie, MD, University of Missouri-Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Axial Myopia Refractive Errors Drug: Oral Riboflavin Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a 1:1:1 double-blinded randomized study for children ages 6-12 year old with axial myopia who will be treated with one of three different doses of oral riboflavin. Expected number of participants is 100.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The researchers involved, the project investigator, and the patients will be blinded from knowing which patient will get which treatment by assigning a number to each patient and having that patient take that number to the pharmacy where they will pick up their riboflavin. The dosage of riboflavin given to the patient will be chosen by the "number" that the patient gives to the pharmacy. There will be no labels revealing the dose of riboflavin that the patient receives. There will be placebo dose which contains a small dose of riboflavin that has been shown to not reach therapeutic levels.
Primary Purpose: Treatment
Official Title: Evaluation of Progression of Myopia in Children Treated With Vitamin B2 and Outdoor Sunlight Exposure
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : October 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Experimental: 200 mg Riboflavin (oral)
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.
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
Other Name: Vitamin B2

Experimental: 400 mg Riboflavin (oral)
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.
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
Other Name: Vitamin B2

Placebo Comparator: 0 mg Riboflavin (oral)
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.
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
Other Name: Vitamin B2




Primary Outcome Measures :
  1. Change in cycloplegic refraction [ Time Frame: 3 years ]
    We will measure the average change in cycloplegic refraction over 3 years in each treatment/study group.


Secondary Outcome Measures :
  1. Change in axial length [ Time Frame: 3 years ]
    Change in axial length over 3 years in each treatment/study group.

  2. Change in keratometry values [ Time Frame: 3 years ]
    Change in keratometry values over 3 years in each study group.

  3. Change in uncorrected best visual acuity [ Time Frame: 3 years ]
    Change in uncorrected best visual acuity over 3 years in each study group.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552016


Contacts
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Contact: Mohannad Al-Samarraie, MD 573-882-1506 alsamarraiem@health.missouri.edu
Contact: Ryan N Mercer, MD 803-740-9673 mercerr@health.missouri.edu

Locations
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United States, Missouri
Eye Institute East Recruiting
Columbia, Missouri, United States, 65201
Contact: Mohannad Al-Samarraie, MD    573-882-7389    alsamarraiem@health.missouri.edu   
Contact    573-882-8920      
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Mohannad Al-Samarraie, MD University of Missouri-Columbia

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Responsible Party: Mohanned Al-Samarraie, MD, Assistant Professor of Clinical Ophthalmology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03552016     History of Changes
Other Study ID Numbers: 2011340 HS
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mohanned Al-Samarraie, MD, University of Missouri-Columbia:
Myopia
Axial Myopia
Children
Refractive Error
Riboflavin
Vitamin B2
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Vitamins
Riboflavin
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents