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Enrolling by Invitation

NCT Number: NCT07537166

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

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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Key information

Conditions

Acupressure

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, North Strict, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular acupoint stimulation

Other

Auricular Eye Point

0.01% concentration atropine drops

Drug

0.5 mL unit dose, preservative-free

0.025% atropine eye drops

Drug

0.5 mL unit dose, preservative-free

Artificial Tears (AT)

Other

0.5 mL unit dose, preservative-free

Primary outcomes

  1. Change in corneal curvature (Keratometry)

    Time frame: 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)

  2. Change in refractive error (Spherical Equivalent)

    Time frame: 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)

  3. Change in amplitude of accommodation

    Time frame: Baseline to 3 months once per week.

    Amplitude of accommodation will be assessed using the push-up method.

    Unit of Measure:

    Diopters (D)

  4. Change in axial length

    Time frame: Baseline to 3 months once per week.

    Axial length will be measured using optical biometry.

    Unit of Measure:

    Millimeters (mm)

  5. Change in anterior chamber depth

    Time frame: Baseline to 3 months once per week.

    Anterior chamber depth will be measured using optical biometry.

    Unit of Measure:

    Millimeters (mm)

  6. Change in intraocular pressure

    Time frame: Baseline to 3 months once per week.

    Intraocular pressure will be measured using non-contact tonometry.

    Unit of Measure:

    mmHg

  7. Change in corneal topographic parameters

    Time frame: 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)

  8. Change in retinal structure assessed by optical coherence tomography

    Time frame: Baseline to 3 months once per week.

    Retinal thickness and macular structure will be evaluated using OCT.

    Unit of Measure:

    Micrometers (μm)

  9. Change in central corneal thickness

    Time frame: Baseline to 3 months once per week.

    Central corneal thickness will be measured using pachymetry.

    Unit of Measure:

    Micrometers (μm)

Other outcomes

  1. Safety monitoring index: Corneal endothelial cell parameters

    Time frame: Baseline to 3 months once per week.

    The following quantitative parameters will be recorded: endothelial cell density (ECD), coefficient of variation in cell size (CV), percentage of hexagonal cells (HEX), and average cell area. These are imaging-derived quantitative measurements rather than a scored scale; therefore, no minimum or maximum scale values apply.

    Normal range:

    ECD: 3,100-5,000 cells/mm² CV: 18-40% Percentage of HEX: 50-70% Average cell area: 230-680 μm²

    Higher ECD and hexagonality generally indicate better corneal endothelial status, whereas lower CV and average cell area indicate more stable endothelial morphology.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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