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

NCT07537166 | Enrolling By Invitation DMC

• 1 other identifier: CMUH114-REC1-146
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Safety monitoring index: Corneal endothelial cell parameters

  Baseline, and every week during the study

Study Arms (6)

Acupoint plus 0.01% Atropine

EXPERIMENTAL

Auricular acupoint stimulation + 0.01% atropine (0.5 mL unit dose, preservative-free)

Other: Auricular acupoint stimulation; Drug: 0.01% concentration atropine drops

0.01% Atropine

PLACEBO COMPARATOR

0.01% atropine (0.5 mL unit dose, preservative-free)

Drug: 0.01% concentration atropine drops

Acupoint plus 0.025% Atropine

EXPERIMENTAL

Auricular acupoint stimulation + 0.025% atropine (0.5 mL unit dose, preservative-free)

Other: Auricular acupoint stimulation; Drug: 0.025% atropine eye drops

0.025% Atropine

PLACEBO COMPARATOR

0.025% atropine (0.5 mL unit dose, preservative-free)

Drug: 0.025% atropine eye drops

Acupoint plus Artificial tears

EXPERIMENTAL

Auricular acupoint stimulation + artificial tears (0.5 mL unit dose, preservative-free)

Other: Auricular acupoint stimulation; Other: Artificial Tears (AT)

Artificial tears

PLACEBO COMPARATOR

Artificial tears (0.5 mL unit dose, preservative-free)

Other: Artificial Tears (AT)

Interventions

Auricular acupoint stimulation OTHER

Auricular Eye Point

Acupoint plus 0.01% Atropine; Acupoint plus 0.025% Atropine; Acupoint plus Artificial tears

0.01% concentration atropine drops DRUG

0.5 mL unit dose, preservative-free

0.01% Atropine; Acupoint plus 0.01% Atropine

0.025% atropine eye drops DRUG

0.5 mL unit dose, preservative-free

0.025% Atropine; Acupoint plus 0.025% Atropine

Artificial Tears (AT) OTHER

0.5 mL unit dose, preservative-free

Acupoint plus Artificial tears; Artificial tears

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-12 years
• Myopia after cycloplegia (spherical equivalent \> -0.5 D)
• Astigmatism and anisometropia \< -2.0 D
• Intraocular pressure \< 21 mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North Strict, 404, Taiwan

Location

MeSH Terms

Interventions

Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)