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

NCT06683287 — Not applicable, Completed, 120 participants, Beijing Tongren Hospital

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

Registry	NCT06683287
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	120 (Actual)
Sponsor	Beijing Tongren Hospital (Other)
Conditions	Myopia
Interventions	red light and distant image screen, red light, distant image screen (Device)
Dates	start 2023-04-10, primary completion 2023-05-15, completion 2023-05-15, first posted 2024-11-12, last updated 2024-11-12
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
red-light	Experimental	Device: 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.
distant-image screen group	Experimental	Device: distant image screen	participants were given a distant-image screen ( RIO-Max2.0; Ruishi Inc), and were asked to use this device for ≥1 hour/day
red-light plus distant image screen	Experimental	Device: red light and 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
control	No intervention		No intervention

red light and distant image screen (Device): red light plus distant image screen, children use these two devices at the same time
red light (Device): children use red light for 3 minutes each time, twice a day
distant image screen (Device): Children in this group were asked to use this device for ≥1 hour/day

+Outcome measures

Primary outcomes

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)

+Eligibility

Sex: All, ages: 8 Years to 12 Years

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.

+Locations (1)

Facility	City	Country	Status
Beijing Tongren Hospital	Beijing, China	China

+Publications

Results publication: 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