AcupressureNCT07537166
0.01% and 0.025% Atropine Eye Drops Combined Auricular Acupoint Stimulation on Myopia Control and Corneal Endothelium Change
A study testing Auricular acupoint stimulation, 0.01% concentration atropine drops and 0.025% atropine eye drops in people with Acupressure, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Acupressure
- What is being tested?
- Auricular acupoint stimulation, 0.01% concentration atropine drops and 0.025% atropine eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-12 years
- Myopia after cycloplegia (spherical equivalent > -0.5 D)
- Astigmatism and anisometropia < -2.0 D
- Intraocular pressure < 21 mmHg
Who cannot join
- Infection
- Ulceration
- Eyelid disorders
- Ear disorders
- Amblyopia or strabismus
- Use of other pharmacological or invasive treatments for myopia during the study period (spectacles allowed)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Acupressure
- Being tested
- Auricular acupoint stimulation, 0.01% concentration atropine drops, 0.025% atropine eye drops, Artificial Tears (AT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupoint stimulationOther
Auricular Eye Point
0.01% concentration atropine dropsDrug
0.5 mL unit dose, preservative-free
0.025% atropine eye dropsDrug
0.5 mL unit dose, preservative-free
Artificial Tears (AT)Other
0.5 mL unit dose, preservative-free
| Study group | Role | What they receive |
|---|---|---|
| Acupoint plus 0.01% Atropine | Experimental | Auricular acupoint stimulation + 0.01% atropine (0.5 mL unit dose, preservative-free) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: 0.025% atropine eye drops |
| Acupoint plus Artificial tears | Experimental | Auricular acupoint stimulation + artificial tears (0.5 mL unit dose, preservative-free) Receives: Other: Auricular acupoint stimulation; Other: Artificial Tears (AT) |
| Artificial tears | Placebo comparator | Artificial tears (0.5 mL unit dose, preservative-free) Receives: Other: Artificial Tears (AT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 3 months once per week.
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)
Measured: Baseline to 3 months once per week.
Change in amplitude of accommodation
Amplitude of accommodation will be assessed using the push-up method.
Unit of Measure:
Diopters (D)
Measured: Baseline to 3 months once per week.
Change in axial length
Axial length will be measured using optical biometry.
Unit of Measure:
Millimeters (mm)
Measured: Baseline to 3 months once per week.
Change in anterior chamber depth
Anterior chamber depth will be measured using optical biometry.
Unit of Measure:
Millimeters (mm)
Measured: Baseline to 3 months once per week.
Change in intraocular pressure
Intraocular pressure will be measured using non-contact tonometry.
Unit of Measure:
mmHg
Measured: Baseline to 3 months once per week.
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)
Measured: Baseline to 3 months once per week.
Change in retinal structure assessed by optical coherence tomography
Retinal thickness and macular structure will be evaluated using OCT.
Unit of Measure:
Micrometers (μm)
Measured: Baseline to 3 months once per week.
Change in central corneal thickness
Central corneal thickness will be measured using pachymetry.
Unit of Measure:
Micrometers (μm)
Measured: Baseline to 3 months once per week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start11 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupressureStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537166
- Sponsor's protocol ID
- CMUH114-REC1-146
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07537166
- Acronym / sponsor ID
- CMUH114-REC1-146
- Conditions
- Acupressure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acupoint plus 0.01% Atropine | Experimental | Other: Auricular acupoint stimulation, Drug: 0.01% concentration atropine dropsAuricular acupoint stimulation + 0.01% atropine (0.5 mL unit dose, preservative-free) |
| 0.01% Atropine | Placebo comparator | Drug: 0.01% concentration atropine drops0.01% atropine (0.5 mL unit dose, preservative-free) |
| Acupoint plus 0.025% Atropine | Experimental | Other: Auricular acupoint stimulation, Drug: 0.025% atropine eye dropsAuricular acupoint stimulation + 0.025% atropine (0.5 mL unit dose, preservative-free) |
| 0.025% Atropine | Placebo comparator | Drug: 0.025% atropine eye drops0.025% atropine (0.5 mL unit dose, preservative-free) |
| Acupoint plus Artificial tears | Experimental | Other: Auricular acupoint stimulation, Other: Artificial Tears (AT)Auricular acupoint stimulation + artificial tears (0.5 mL unit dose, preservative-free) |
| Artificial tears | Placebo comparator | Other: Artificial Tears (AT)Artificial tears (0.5 mL unit dose, preservative-free) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-12 years
- Myopia after cycloplegia (spherical equivalent > -0.5 D)
- Astigmatism and anisometropia < -2.0 D
- Intraocular pressure < 21 mmHg
Key exclusion criteria (11 listed)
- Infection
- Ulceration
- Eyelid disorders
- Ear disorders
- Amblyopia or strabismus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupoint stimulationAuricular Eye Point | Other | Acupoint plus 0.01% Atropine, Acupoint plus 0.025% Atropine, Acupoint plus Artificial tears |
| 0.01% concentration atropine drops0.5 mL unit dose, preservative-free | Drug | 0.01% Atropine, Acupoint plus 0.01% Atropine |
| 0.025% atropine eye drops0.5 mL unit dose, preservative-free | Drug | 0.025% Atropine, Acupoint plus 0.025% Atropine |
| Artificial Tears (AT)0.5 mL unit dose, preservative-free | Other | Acupoint plus Artificial tears, Artificial tears |
Primary outcome
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)
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)
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)
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)
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)
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
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupoint stimulation, 0.01% concentration atropine drops and 0.025% atropine eye drops in people with Acupressure, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corneal curvature (Keratometry) (time frame: Baseline to 3 months once per week.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.