The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children

Study Overview
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Brief Summary
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Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children. The investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia The hypotheses of this study are as follows: Periocular acupressure is effective for myopia progression delay. The study aims to include 56 participants.

Official Title
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An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study

Conditions
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Myopia

Intervention / Treatment
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* Device: massager


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 7-12 years Spherical equivalent greater than -5D Individuals without strabismus, anistopia Willingness to participate in the study Exclusion Criteria: The presence of a related disease such as cataract, glaucoma, or other eye disease. Individuals who were received ocular or scalp trauma. Individuals who were received ocular surgery and had ocular wound. Individuals who were adapted bifocal lense. Individuals suffering fever or bad conditions. Individuals suffering systemic or neurologic disease. Indibiduals who were receiving other therapy during the period of study Individuals who did not comply with the treatment which affected myopia progression.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>A series of acupressure sessions within six months from the baseline | Device: massager<br>* The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.<br>* Other names: proprietary name : Nurieye-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive error | Change from baseline in the refractive erros will be used. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Change from baseline in the axial length will be used. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Children, Acupressure, Refractive error, Axial length, Korean medicine