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

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT06683287
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2023-04-10
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-08
• Last Update Submitted: 2024-11-08
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

  2. Corneal astigmatism ≤ 1.25D. 4. Interocular refraction discrepancy ≤ 1.5D. 5. Near-distance exophoria < 10 prism diopters (△) and far-distance exophoria < 6 prism diopters (△).

  3. 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.

  2. 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.

  3. Individuals with conditions like Tourette's syndrome or epilepsy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in axial length	one year	Axial length was measured using an optical biometer (Colombo IOL, Moptim)
Changes in spherical equivalent error	one year	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)

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China