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

Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06683287
Enrollment
120
Registered
2024-11-12
Start date
2023-04-10
Completion date
2023-05-15
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

myopia, red-light, distant-image screen

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.

Interventions

DEVICEred light and distant image screen

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

DEVICEred light

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

DEVICEdistant image screen

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

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in axial lengthone yearAxial length was measured using an optical biometer (Colombo IOL, Moptim)
Changes in spherical equivalent errorone yearSpherical 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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026