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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Drug: Atropine; Device: auricular acupoint stimulation

• Registration Number: NCT02055378
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

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 Timeline

• Study Start: 2011-01
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-02-02
• Study First Submitted QC: 2014-02-03
• Last Update Submitted: 2014-02-03
• Study First Posted: 2014-02-05
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
auricular acupoint stimulation	Atropine	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.
auricular acupoint stimulation	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.
Atropine	Atropine	topical 0.125% atropine was given nightly during the study period.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation; 🇨🇳 Taipei, New Taipei City, Taiwan