Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children

Beijing Tongren Hospital120 enrolled

Overview

This study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia treatment.

This was a randomized clinical trial. Children aged 8 to 10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following treatment group: RL, DIT, RL plus DIT, and control in a 1:1:1:1 ratio. The primary outcomes were one-year change in SER and axial length.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Myopia

Interventions

red light and distant image screenDEVICE

red light plus distant image screen, children use these two devices at the same time

red lightDEVICE

children use red light for 3 minutes each time, twice a day

distant image screenDEVICE

Children in this group were asked to use this device for ≥1 hour/day

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Age between 8 and 10 years old. 2. The spherical equivalent error after pupil dilation was between -1.0 D and -1.5D. 3\. Corneal astigmatism ≤ 1.25D. 4. Interocular refraction discrepancy ≤ 1.5D. 5. Near-distance exophoria \< 10 prism diopters (△) and far-distance exophoria \< 6 prism diopters (△). 6\. Willingness to participate in the study and signed informed consent. Exclusion Criteria: * 1\. Intraocular pressure was below 10 mmHg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders. 3\. Children currently using atropine or orthokeratology for myopia control. 4. Patients with systemic and immune disorders such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc. 5\. Individuals with conditions like Tourette's syndrome or epilepsy.

Locations (1)

Beijing Tongren Hospital

Beijing, China, China

Outcomes

Primary Outcomes

Changes in axial length

Axial length was measured using an optical biometer (Colombo IOL, Moptim)

Time frame: one year

Changes in spherical equivalent error

Spherical equivalent error was calculated from the dioptric powers of the sphere and half of the cylinder.The children's pupils were dilated using tropicamide eyedrops, then SER was subsequently measured using an auto refractor (ARK-510A, Nidek Co Ltd)

Time frame: one year

Data from ClinicalTrials.gov

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