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

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation (Other)

Overall Status

Completed

CT.gov ID

NCT02055378

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: Atropine Device: auricular acupoint stimulation	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: auricular acupoint stimulation 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 topical 0.125% atropine eye drops Other Names: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan) Device: auricular acupoint stimulation 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. Other Names: a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)
Active Comparator: Atropine topical 0.125% atropine was given nightly during the study period.	Drug: Atropine topical 0.125% atropine eye drops Other Names: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

Arm

Intervention/Treatment

Experimental: auricular acupoint stimulation

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

topical 0.125% atropine eye drops

Other Names:

0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

Device: auricular acupoint stimulation

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.

Other Names:

a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)

Active Comparator: Atropine

topical 0.125% atropine was given nightly during the study period.

Drug: Atropine

topical 0.125% atropine eye drops

Other Names:

0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

Outcome Measures

Primary Outcome Measures

the change in spherical equivalent (SE) [SE measured at 3, 6, 9, 12 months.]
We measured the myopic progression (change in SE) of all the participants for at least six months.

Secondary Outcome Measures

axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) [AL, ACD, and IOP measure at 3, 6, 9, 12 months]
We measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.