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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

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

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

More Information

• Responsible Party: Mohanned Al-Samarraie, MD, Assistant Professor of Clinical Ophthalmology, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03552016
• Other Study ID Numbers: 2011340 HS
• First Posted: June 11, 2018
• Last Update Posted: April 22, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Myopia; Refractive Errors; Eye Diseases; Riboflavin; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Vitamin B Complex; Photosensitizing Agents; Dermatologic Agents