CompletedNot Applicable

LED Low-Intensity Red Light for Myopia Control in Youth: Efficacy and Safety Study

China40 participantsStarted 2025-04-16

Plain-language summary

The purpose of this clinical trial was to investigate the efficacy and safety of repetitive low-intensity single-wavelength red light from an LED light source in controlling myopia progression in children and adolescents.

Who can participate

Age range8 Years – 12 Years

SexALL

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Inclusion criteria

✓. Age: 8-12 years old
✓. Simple myopia: equivalent spherical lens ≤ -0.5D and \> -6.0D after any cycloplegia, astigmatism ≤ 2.5D, anisometropia ≤ 1.5D
✓. The best corrected visual acuity in one eye is 0.8 and above
✓. Normal fundus, or only leopard-shaped fundus
✓. Sign informed consent and be able to participate in the study

Exclusion criteria

✕. Rule out hereditary myopia
✕. The subject has other congenital eye diseases, such as congenital cataract, congenital glaucoma, etc
✕. Presence of strabismus or other binocular vision abnormalities
✕. refractive media opacity: corneal opacity, cataract or intraocular lens surgery
✕. There are eye diseases that affect retinal function
✕. Children who had used or were using orthokeratology, atropine and other myopia control measures could be enrolled after stopping treatment for three months
✕. There are other systemic disease abnormalities
✕. Other reasons that the research doctor considers unsuitable for inclusion in the project

What they're measuring

Subjects in the intervention group received red light treatment with 1.6mW LED light source during 3 months

Timeframe: 1 week，1 ,3months

Trial details

NCT IDNCT07375589

SponsorShanghai Eye Disease Prevention and Treatment Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Myopia trials