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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: Atropine; Device: auricular acupoint stimulation

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City
    • Taipei, New Taipei City, Taiwan, 231
      • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Investigators: Study Chair: Liao, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 2, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Estimate): February 5, 2014
• Last Update Submitted That Met QC Criteria: February 3, 2014
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: atropine; axial length; myopia; anterior chamber depth; auricular acupoint
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Adjuvants, Anesthesia; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Atropine
• Other Study ID Numbers: 99-IRB-032-XD