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0.01% and 0.025% Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change
Sponsor: China Medical University Hospital
Summary
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.
Official title: A Pilot Randomized, Partially Double Blind, Placebo-Controlled Trial of 0.01% and 0.025%Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change
Key Details
Gender
All
Age Range
6 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2026-02-27
Completion Date
2027-03-31
Last Updated
2026-04-17
Healthy Volunteers
No
Conditions
Interventions
Auricular acupoint stimulation
Auricular Eye Point
0.01% concentration atropine drops
0.5 mL unit dose, preservative-free
0.025% atropine eye drops
0.5 mL unit dose, preservative-free
Artificial Tears (AT)
0.5 mL unit dose, preservative-free
Locations (1)
China Medical University Hospital
Taichung, North Strict, Taiwan