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

NCT07537166 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-06-04

No results posted yet for this study

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.

Conditions

  • Acupressure

Interventions

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

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-11
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537166 on ClinicalTrials.gov