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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Atropine
auricular acupoint stimulation
Sponsored by
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia, atropine, anterior chamber depth, auricular acupoint, axial length

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

auricular acupoint stimulation

Atropine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

the change in spherical equivalent (SE)
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)
We measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months.

Full Information

First Posted
February 2, 2014
Last Updated
February 3, 2014
Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02055378
Brief Title
the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Official Title
the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, atropine, anterior chamber depth, auricular acupoint, axial length

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
auricular acupoint stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Atropine
Arm Type
Active Comparator
Arm Description
topical 0.125% atropine was given nightly during the study period.
Intervention Type
Drug
Intervention Name(s)
Atropine
Other Intervention Name(s)
0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)
Intervention Description
topical 0.125% atropine eye drops
Intervention Type
Device
Intervention Name(s)
auricular acupoint stimulation
Other Intervention Name(s)
a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change in spherical equivalent (SE)
Description
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 Outcome Measure Information:
Title
axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao, MD
Organizational Affiliation
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
Taipei
State/Province
New Taipei City
ZIP/Postal Code
231
Country
Taiwan

12. IPD Sharing Statement

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

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