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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| 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 |
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| control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| red light and distant image screen | Device | red light plus distant image screen, children use these two devices at the same time |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | China | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40201319 | Derived | 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. |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| red light | Device | children use red light for 3 minutes each time, twice a day |
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| distant image screen | Device | Children in this group were asked to use this device for ≥1 hour/day |
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