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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acupressure
• Intervention / Treatment: Other: Auricular acupoint stimulation; Drug: 0.01% concentration atropine drops; Drug: 0.025% atropine eye drops; Other: Artificial Tears (AT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • North Strict
    • Taichung, North Strict, Taiwan, 404
      • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupoint plus 0.01% Atropine; Auricular acupoint stimulation + 0.01% atropine (0.5 mL unit dose, preservative-free)	Other: Auricular acupoint stimulation; Auricular Eye Point; Drug: 0.01% concentration atropine drops; 0.5 mL unit dose, preservative-free
Placebo Comparator: 0.01% Atropine; 0.01% atropine (0.5 mL unit dose, preservative-free)	Drug: 0.01% concentration atropine drops; 0.5 mL unit dose, preservative-free
Experimental: Acupoint plus 0.025% Atropine; Auricular acupoint stimulation + 0.025% atropine (0.5 mL unit dose, preservative-free)	Other: Auricular acupoint stimulation; Auricular Eye Point; Drug: 0.025% atropine eye drops; 0.5 mL unit dose, preservative-free
Placebo Comparator: 0.025% Atropine; 0.025% atropine (0.5 mL unit dose, preservative-free)	Drug: 0.025% atropine eye drops; 0.5 mL unit dose, preservative-free
Experimental: Acupoint plus Artificial tears; Auricular acupoint stimulation + artificial tears (0.5 mL unit dose, preservative-free)	Other: Auricular acupoint stimulation; Auricular Eye Point; Other: Artificial Tears (AT); 0.5 mL unit dose, preservative-free
Placebo Comparator: Artificial tears; Artificial tears (0.5 mL unit dose, preservative-free)	Other: Artificial Tears (AT); 0.5 mL unit dose, preservative-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in corneal curvature (Keratometry)	Mean corneal curvature will be measured using an autorefractor keratometer. The average keratometric value (K) will be recorded. Unit of Measure: Diopters (D)	Baseline, 3 months, and 6 months
Change in refractive error (Spherical Equivalent)	Spherical equivalent will be calculated as sphere + 1/2 cylinder based on cycloplegic refraction. Unit of Measure: Diopters (D)	Baseline, 3 months, and 6 months
Change in amplitude of accommodation	Amplitude of accommodation will be assessed using the push-up method. Unit of Measure: Diopters (D)	Baseline, 3 months, and 6 months
Change in axial length	Axial length will be measured using optical biometry. Unit of Measure: Millimeters (mm)	Baseline, 3 months, and 6 months
Change in anterior chamber depth	Anterior chamber depth will be measured using optical biometry. Unit of Measure: Millimeters (mm)	Baseline, 3 months, and 6 months
Change in intraocular pressure	Intraocular pressure will be measured using non-contact tonometry. Unit of Measure: mmHg	Baseline, 3 months, and 6 months
Change in corneal topographic parameters	Corneal topography will be used to assess corneal surface characteristics, including corneal astigmatism and curvature distribution. Unit of Measure: Diopters (D)	Baseline, 3 months, and 6 months
Change in retinal structure assessed by optical coherence tomography	Retinal thickness and macular structure will be evaluated using OCT. Unit of Measure: Micrometers (μm)	Baseline, 3 months, and 6 months
Change in central corneal thickness	Central corneal thickness will be measured using pachymetry. Unit of Measure: Micrometers (μm)	Baseline, 3 months, and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety monitoring index: Corneal endothelial cell parameters	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.	Baseline, and every week during the study

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ophthalmic Solutions; Pharmaceutical Solutions; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Solutions; Specialty Uses of Chemicals; Lubricants; Lubricant Eye Drops
• Other Study ID Numbers: CMUH114-REC1-146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No