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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

Primary Purpose

Myopia

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

0.25 % atropine

0.5 % atropine

0.25 % atropine+auricular acupoints

About this trial

This is an interventional treatment trial for Myopia focused on measuring myopia, auricular acupoint, atropine, RCT

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
The astigmatism and anisometropia were less than 2.0 D,
IOP was less than 21 mmHg.

Exclusion Criteria:

the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
individuals with amblyopia or strabismus,
individuals received any other therapies in the period of study,
individuals suffering some sort of haemostasis disorder,
individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days

Sites / Locations

China Medical University

Outcomes

Primary Outcome Measures

the progression of myopia degree, axial length elongation of eye

Secondary Outcome Measures

Full Information

NCT ID

NCT00457717

First Posted

April 5, 2007

Last Updated

April 5, 2007

Sponsor

China Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT00457717

Brief Title

Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

China Medical University, China

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.

Detailed Description

A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms: 21 treated with the 0.25 % atropine each night (0.25A). 20 treated with the 0.5 % atropine each night (0.5A). 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E). This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

myopia, auricular acupoint, atropine, RCT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

0.25 % atropine

Intervention Type

Drug

Intervention Name(s)

0.5 % atropine

Intervention Type

Procedure

Intervention Name(s)

0.25 % atropine+auricular acupoints

Primary Outcome Measure Information:

Title

the progression of myopia degree, axial length elongation of eye

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction, The astigmatism and anisometropia were less than 2.0 D, IOP was less than 21 mmHg. Exclusion Criteria: the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders, individuals with amblyopia or strabismus, individuals received any other therapies in the period of study, individuals suffering some sort of haemostasis disorder, individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shih-Liang Chang, PhD

Organizational Affiliation

China Medical University, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

China Medical University

City

Taichung City

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

7148977

Citation

Goss DA. Attempts to reduce the rate of increase of myopia in young people--a critical literature review. Am J Optom Physiol Opt. 1982 Oct;59(10):828-41. doi: 10.1097/00006324-198210000-00010.

Results Reference

background

PubMed Identifier

15008558

Citation

Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.

Results Reference

background

PubMed Identifier

11874738

Citation

Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.

Results Reference

background

PubMed Identifier

10048351

Citation

Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. doi: 10.1089/jop.1999.15.85.

Results Reference

result

PubMed Identifier

2615447

Citation

Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. No abstract available.

Results Reference

result

PubMed Identifier

19028329

Citation

Liang CK, Ho TY, Li TC, Hsu WM, Li TM, Lee YC, Ho WJ, Cheng JT, Tzeng CY, Liu IT, Chang SL. A combined therapy using stimulating auricular acupoints enhances lower-level atropine eyedrops when used for myopia control in school-aged children evaluated by a pilot randomized controlled clinical trial. Complement Ther Med. 2008 Dec;16(6):305-10. doi: 10.1016/j.ctim.2008.04.007. Epub 2008 May 29.

Results Reference

derived

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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

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