This randomized, double-blind, placebo-controlled pilot trial evaluates the efficacy and safety of low-dose atropine (0.01%, 0.025%) combined with auricular acupoint stimulation for myopia control in children. While 0.05% atropine is effective, it may pose corneal toxicity risks, highlighting the need for safer alternatives. Auricular acupuncture has shown potential benefits in systematic reviews. A total of 420 children aged 6-12 will be randomized into six groups receiving different treatments or placebo, with a 12-week follow-up. The auricular Eye Point will be stimulated, and comprehensive visual and ocular assessments will be conducted, including corneal endothelial monitoring. This study aims to determine the synergistic effect of combined therapy and provide a safer treatment option, laying the foundation for future large-scale trials.
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Change in corneal curvature (Keratometry)
Timeframe: Baseline, 3 months, and 6 months
Change in refractive error (Spherical Equivalent)
Timeframe: Baseline, 3 months, and 6 months
Change in amplitude of accommodation
Timeframe: Baseline, 3 months, and 6 months
Change in axial length
Timeframe: Baseline, 3 months, and 6 months
Change in anterior chamber depth
Timeframe: Baseline, 3 months, and 6 months
Change in intraocular pressure
Timeframe: Baseline, 3 months, and 6 months
Change in corneal topographic parameters
Timeframe: Baseline, 3 months, and 6 months
Change in retinal structure assessed by optical coherence tomography
Timeframe: Baseline, 3 months, and 6 months
Change in central corneal thickness
Timeframe: Baseline, 3 months, and 6 months