Acupressure
Conditions
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.
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.
Interventions
Auricular Eye Point
0.5 mL unit dose, preservative-free
0.5 mL unit dose, preservative-free
0.5 mL unit dose, preservative-free
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal curvature (Keratometry) | Baseline, 3 months, and 6 months | 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) | Baseline, 3 months, and 6 months | Spherical equivalent will be calculated as sphere + 1/2 cylinder based on cycloplegic refraction. Unit of Measure: Diopters (D) |
| Change in amplitude of accommodation | Baseline, 3 months, and 6 months | Amplitude of accommodation will be assessed using the push-up method. Unit of Measure: Diopters (D) |
| Change in axial length | Baseline, 3 months, and 6 months | Axial length will be measured using optical biometry. Unit of Measure: Millimeters (mm) |
| Change in anterior chamber depth | Baseline, 3 months, and 6 months | Anterior chamber depth will be measured using optical biometry. Unit of Measure: Millimeters (mm) |
| Change in intraocular pressure | Baseline, 3 months, and 6 months | Intraocular pressure will be measured using non-contact tonometry. Unit of Measure: mmHg |
| Change in corneal topographic parameters | Baseline, 3 months, and 6 months | 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 | Baseline, 3 months, and 6 months | Retinal thickness and macular structure will be evaluated using OCT. Unit of Measure: Micrometers (μm) |
| Change in central corneal thickness | Baseline, 3 months, and 6 months | Central corneal thickness will be measured using pachymetry. Unit of Measure: Micrometers (μm) |
Countries
Taiwan
Outcome results
None listed