the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

Study Overview
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Brief Summary
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To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.

Detailed Description
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Myopia has been an increasing problem among school children, especially in Asian countries. High myopia is not only a refractive problem, but also a disease that can result in a number of sight-threatening complications such as macular degeneration, retinal detachment, glaucoma, and cataract. Atropine is a long-acting non-selective muscarinic antagonist that blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera and suppress the elongation of axial length. Acupuncture and acupressure have been widely used in traditional Chinese medicine for thousands of years. Auricular acupoint stimulation by acupuncture or acupressure has been reported to improve visual acuity in myopic patients. Therefore, we want to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those who treated with atropine alone.

Official Title
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the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

Conditions
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Myopia

Intervention / Treatment
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* Drug: Atropine
* Device: auricular acupoint stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged from 6 to 12 years with myopia, defined as spherical equivalent (SE) of -0.5 diopter (D) or less, were recruited from the outpatient clinics from January 2011 to June 2012. Exclusion Criteria: (1) abnormal IOP (>21 mmHg) at presentation, (2) astigmatism or anisometropia of more than 1.5 D, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.

Ages Eligible for Study
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Minimum Age: 6 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: auricular acupoint stimulation<br>Five auricular acupoints were selected for taping stimulation by using a 1-mm alloy ball by fingers three times a day, each time for five minutes over the five selected acupoints. Topical 0.125% atropine was given nightly. | Drug: Atropine<br>* topical 0.125% atropine eye drops<br>* Other names: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan);Device: auricular acupoint stimulation<br>* Five auricular acupoints (Shenmen, Xin, Yan, Mu 1 and Mu 2) Tapping stimulation was administered by using a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan) three times a day, each time for five minutes.<br>* Other names: a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan);|
| Active Comparator: Atropine<br>topical 0.125% atropine was given nightly during the study period. | Drug: Atropine<br>* topical 0.125% atropine eye drops<br>* Other names: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change in spherical equivalent (SE) | We measured the myopic progression (change in SE) of all the participants for at least six months. | SE measured at 3, 6, 9, 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) | We measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months. | AL, ACD, and IOP measure at 3, 6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, atropine, anterior chamber depth, auricular acupoint, axial length