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
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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
* Children aged 6-12 years
* Myopia after cycloplegia (spherical equivalent \> -0.5 D)
* Astigmatism and anisometropia \< -2.0 D
* Intraocular pressure \< 21 mmHg
Exclusion Criteria:
* Infection
* Ulceration
* Eyelid disorders
* Ear disorders
* Amblyopia or strabismus
* Use of other pharmacological or invasive treatments for myopia during the study period (spectacles allowed)
* Hematologic or other systemic diseases
* Non-compliance with study protocol for more than 7 days
* History of atropine allergy
* Previous or current use of contact lenses or orthokeratology lenses
* Previous or current use of bifocal or progressive lenses
Primary outcome measure(s)
Change in corneal curvature (Keratometry) — Baseline to 3 months once per week. Mean corneal curvature will be measured using an autorefractor keratometer. The average keratometric value (K) will be recorded.
Unit of Measure:
Diopters (D)
Change in refractive error (Spherical Equivalent) — Baseline to 3 months once per week. Spherical equivalent will be calculated as sphere + 1/2 cylinder based on cycloplegic refraction.
Unit of Measure:
Diopters (D)
Change in amplitude of accommodation — Baseline to 3 months once per week. Amplitude of accommodation will be assessed using the push-up method.
Unit of Measure:
Diopters (D)
Change in axial length — Baseline to 3 months once per week. Axial length will be measured using optical biometry.
Unit of Measure:
Millimeters (mm)
Change in anterior chamber depth — Baseline to 3 months once per week. Anterior chamber depth will be measured using optical biometry.
Unit of Measure:
Millimeters (mm)
Change in intraocular pressure — Baseline to 3 months once per week. Intraocular pressure will be measured using non-contact tonometry.
Unit of Measure:
mmHg
Change in corneal topographic parameters — Baseline to 3 months once per week. Corneal topography will be used to assess corneal surface characteristics, including corneal astigmatism and curvature distribution.
Unit of Measure:
Diopters (D)
Change in retinal structure assessed by optical coherence tomography — Baseline to 3 months once per week. Retinal thickness and macular structure will be evaluated using OCT.
Unit of Measure:
Micrometers (μm)
Change in central corneal thickness — Baseline to 3 months once per week. Central corneal thickness will be measured using pachymetry.
Unit of Measure:
Micrometers (μm)
Trial sites (1)
Facility
City
Region
Status
China Medical University Hospital
Taichung
North Strict
More China Medical University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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