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

NCT ID: NCT06683287

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2023-05-15

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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red-light

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.

Group Type EXPERIMENTAL

red light

Intervention Type DEVICE

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

distant-image screen group

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

Group Type EXPERIMENTAL

distant image screen

Intervention Type DEVICE

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

red-light plus distant image screen

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

Group Type EXPERIMENTAL

red light and distant image screen

Intervention Type DEVICE

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

control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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red light and distant image screen

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

Intervention Type DEVICE

red light

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

Intervention Type DEVICE

distant image screen

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tongren Hospital

OTHER

Sponsor Role lead

Responsible Party

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cao kai

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tongren Hospital

Beijing, China, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40201319 (View on PubMed)

Other Identifiers

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BeijingTH2024qiao

Identifier Type: -

Identifier Source: org_study_id

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