By InvitationNot Applicable

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

Taiwan420 participantsStarted 2026-04-11

Plain-language 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.

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in corneal curvature (Keratometry)

Timeframe: Baseline to 3 months once per week.

Change in refractive error (Spherical Equivalent)

Timeframe: Baseline to 3 months once per week.

Change in amplitude of accommodation

Timeframe: Baseline to 3 months once per week.

Change in axial length

Timeframe: Baseline to 3 months once per week.

Change in anterior chamber depth

Timeframe: Baseline to 3 months once per week.

Change in intraocular pressure

Timeframe: Baseline to 3 months once per week.

Change in corneal topographic parameters

Timeframe: Baseline to 3 months once per week.

Trial details

NCT IDNCT07537166

SponsorChina Medical University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Acupressure trials

Plain-language summary

Who can participate

Age range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in corneal curvature (Keratometry)

Timeframe: Baseline to 3 months once per week.

Change in refractive error (Spherical Equivalent)

Timeframe: Baseline to 3 months once per week.

Change in amplitude of accommodation

Timeframe: Baseline to 3 months once per week.

Change in axial length

Timeframe: Baseline to 3 months once per week.

Change in anterior chamber depth

Timeframe: Baseline to 3 months once per week.

Change in intraocular pressure

Timeframe: Baseline to 3 months once per week.

Change in corneal topographic parameters

Timeframe: Baseline to 3 months once per week.