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

NCT06683287 | Completed

• 1 other identifier: BeijingTH2024qiao
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia; red-light; distant-image screen

Outcome Measures

Primary Outcomes (2)

• Changes in axial length

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

  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)

  one year

Study Arms (4)

red-light

EXPERIMENTAL

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.

Device: red light

distant-image screen group

EXPERIMENTAL

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

Device: distant image screen

red-light plus distant image screen

EXPERIMENTAL

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

Device: red light and distant image screen

control

NO INTERVENTION

No intervention

Interventions

red light and distant image screen DEVICE

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

red-light plus distant image screen

red light DEVICE

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

red-light

distant image screen DEVICE

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

distant-image screen group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Age between 8 and 10 years old. 2. The spherical equivalent error after pupil dilation was between -1.0 D and -1.5D.
• \. Corneal astigmatism ≤ 1.25D. 4. Interocular refraction discrepancy ≤ 1.5D. 5. Near-distance exophoria \< 10 prism diopters (△) and far-distance exophoria \< 6 prism diopters (△).
• \. Willingness to participate in the study and signed informed consent.

You may not qualify if:

• \. 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.
• \. 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.
• \. Individuals with conditions like Tourette's syndrome or epilepsy.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China, 100730, China

Location

Related Publications (1)

• Yang K, Wang Y, Li X, Liu S, Shi H, Qiao L. One-year changes in axial length and refraction in children using low-level red light and distant-image screen for myopia control: a randomized controlled trial. Front Med (Lausanne). 2025 Mar 25;12:1542620. doi: 10.3389/fmed.2025.1542620. eCollection 2025.

  PMID: 40201319 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: April 10, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)