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

Capital Medical University

Status: Completed

Conditions: Myopia

Treatments: Device: red light; Device: red light and distant image screen; Device: distant image screen

Study type: Interventional

Funder types: Other

Identifiers

NCT06683287

BeijingTH2024qiao

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

red-light

Experimental group

Description:

Children in this group received a red-light apparatus (LS-03B; Yishiliang Inc), which has been deemed safe by the State Administration for Market Regulation of China. They were directed to utilize this apparatus twice a day for 3-minute sessions, ensuring a gap of over 4 hours between each use.

Treatment:

Device: red light

distant-image screen group

Experimental group

Description:

participants were given a distant-image screen ( RIO-Max2.0; Ruishi Inc), and were asked to use this device for ≥1 hour/day

Treatment:

Device: distant image screen

red-light plus distant image screen

Experimental group

Description:

For this group, participants were given a red-light device (LS-03B; Yishiliang Inc) and a distance image screen device ( RIO-Max2.0; Ruishi Inc), and were asked to use red-light twice a day for 3-minute sessions, ensuring a gap of over 4 hours between each use, and use distant image screen for ≥1 hour/day

Treatment:

Device: red light and distant image screen

control

No Intervention group

Description:

No intervention