Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control

Sun Yat-sen University

Status: Unknown

Conditions: Myopia; Refractive Errors; Eye Diseases

Treatments: Device: Low-level Red-light Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04073238

2019KYPJ093

Details and patient eligibility

About

The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age at enrolment: 8-13 years
2. Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
3. Astigmatism of 2.50 D or less
4. Anisometropia of 1.5 D or less
5. Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
6. Parents' understanding and acceptance of random allocation of grouping

Exclusion criteria

1. Strabismus and binocular vision abnormalities in either eye
2. Ocular abnormalities in either eye or other systemic abnormalities
3. Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
4. Other contraindications in either eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Single vision spectacle lens

No Intervention group

Description:

Single vision lens with power for correcting distance refraction.

Repeated low-level red-light therapy

Experimental group

Description:

Single vision lens \& repeated low-level red-light therapy

Treatment:

Device: Low-level Red-light Therapy