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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

NCT ID: NCT00457717

Last Updated: 2007-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-07-31

Brief Summary

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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

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A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:

1. 21 treated with the 0.25 % atropine each night (0.25A).
2. 20 treated with the 0.5 % atropine each night (0.5A).
3. 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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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0.25 % atropine

Intervention Type DRUG

0.5 % atropine

Intervention Type DRUG

0.25 % atropine+auricular acupoints

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Principal Investigators

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Shih-Liang Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Locations

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China Medical University

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 7148977 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15008558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11874738 (View on PubMed)

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.

Reference Type RESULT
PMID: 10048351 (View on PubMed)

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

Reference Type RESULT
PMID: 2615447 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19028329 (View on PubMed)

Other Identifiers

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DMR94-IRB-49

Identifier Type: -

Identifier Source: org_study_id