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

NCT02055378 | Completed DMC

• 1 other identifier: 99-IRB-032-XD
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia; atropine; anterior chamber depth; auricular acupoint; axial length

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP)

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

Study Arms (2)

auricular acupoint stimulation

EXPERIMENTAL

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; Device: auricular acupoint stimulation

Atropine

ACTIVE COMPARATOR

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

Drug: Atropine

Interventions

Atropine DRUG

topical 0.125% atropine eye drops

Also known as: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

Atropine; auricular acupoint stimulation

auricular acupoint stimulation DEVICE

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.

Also known as: a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)

auricular acupoint stimulation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Taipei, New Taipei City, 231, Taiwan

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Liao, MD

  Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2014
• First Posted: February 5, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 5, 2014

Record last verified: 2012-12

Locations

TW (1)