The Clinical Trial of Myopia Control in Schoolchildren Using the Repeated Low-Level Red-Light Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Enrollment
- 264
- Locations
- 4
- Primary Endpoint
- Axial length change (mm)
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.
Detailed Description
Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age at enrolment: 8-13 years
- •Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
- •Astigmatism of 2.50 D or less
- •Anisometropia of 1.5 D or less
- •Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
- •Parents' understanding and acceptance of random allocation of grouping
Exclusion Criteria
- •Strabismus and binocular vision abnormalities in either eye
- •Ocular abnormalities in either eye or other systemic abnormalities
- •Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
- •Other contraindications in either eye
Outcomes
Primary Outcomes
Axial length change (mm)
Time Frame: 1 month, 3 months, 6 months and 1 year
Axial length change (mm) is characterized as the difference between each follow-up visit and baseline values. The IOLMaster is used to measure axial length (mm).
Secondary Outcomes
- Cycloplegic spherical equivalent change (Diopter)(1 month, 3 months, 6 months and 1 year)
- Corneal curvature change (mm)(1 month, 3 months, 6 months and 1 year)
- Anterior chamber depth change (mm)(1 month, 3 months, 6 months and 1 year)
- White to white change (mm)(1 month, 3 months, 6 months and 1 year)
- Visual acuity change(1 month, 3 months, 6 months and 1 year)
- Incidence of treatment-emergent adverse events(1 year)