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

N/ACompletedNCT02055378

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation73 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

AtropineDRUG

topical 0.125% atropine eye drops

auricular acupoint stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, New Taipei City, Taiwan

Outcomes

Primary Outcomes

the change in spherical equivalent (SE)

We measured the myopic progression (change in SE) of all the participants for at least six months.

Time frame: SE measured at 3, 6, 9, 12 months.

Secondary Outcomes

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.

Time frame: AL, ACD, and IOP measure at 3, 6, 9, 12 months

Data from ClinicalTrials.gov

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