NCT07537166

0.01% and 0.025% Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: China Medical University Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a randomized, double-blind, placebo-controlled pilot clinical trial designed to investigate the efficacy and safety of low-concentration atropine eye drops (0.01% and 0.025%) combined with auricular acupoint stimulation in controlling myopia in children. Although 0.05% atropine has been proven effective in slowing the progression of myopia, higher concentrations may pose a risk of corneal endothelial toxicity. Therefore, alternative strategies that balance efficacy and safety are needed. Auricular acupuncture, a traditional Chinese medicine (TCM) technique, has shown potential benefits for myopia control in children in systematic reviews. This study aims to evaluate the synergistic effects of combining both interventions. A total of 420 children aged 6 to 12 years are expected to be recruited and randomly assigned into six groups receiving different concentrations of atropine, auricular acupoint stimulation, or placebo treatment. The study will include a 12-week follow-up period. Auricular Eye Point, which is commonly used in clinical practice, will be stimulated. Each participant will undergo a comprehensive assessment of visual function, including keratometer, spherical equivalent, Amplitude of accommodation, axial length, anterior chamber depth, intraocular pressure, corneal topographic map, optical coherence tomography, central corneal thickness. Corneal endothelial cell parameters will also be monitored to evaluate safety. This study aims to confirm the adjunctive effect of auricular acupoint stimulation combined with low-concentration atropine in controlling myopia and to provide a safer, low-side-effect treatment option for children. The findings are expected to lay the groundwork for future large-scale clinical trials.

Conditions

• Acupressure

Interventions

Type	Name	Description
OTHER	Auricular acupoint stimulation	Auricular Eye Point
DRUG	0.01% concentration atropine drops	0.5 mL unit dose, preservative-free
DRUG	0.025% atropine eye drops	0.5 mL unit dose, preservative-free
OTHER	Artificial Tears (AT)	0.5 mL unit dose, preservative-free

Timeline

• Start date: 2026-02-27
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Taiwan