Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops - Full Text View

Purpose

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.

Condition	Intervention	Phase
Myopia	Drug: 0.25 % atropine Drug: 0.5 % atropine Procedure: 0.25 % atropine+auricular acupoints	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Atropine Atropine sulfate

U.S. FDA Resources

Further study details as provided by China Medical University, China:

Primary Outcome Measures:

the progression of myopia degree, axial length elongation of eye

Estimated Enrollment:	60
Study Start Date:	July 2005
Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457717

Locations

Taiwan
China Medical University
Taichung City, Taiwan

Sponsors and Collaborators

China Medical University, China

Investigators

Principal Investigator:

Shih-Liang Chang, PhD

China Medical University, Taiwan

More Information

Publications:

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.

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

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.

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

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. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2008 May 29.

ClinicalTrials.gov Identifier:	NCT00457717 History of Changes
Other Study ID Numbers:	DMR94-IRB-49
Study First Received:	April 5, 2007
Last Updated:	April 5, 2007
Health Authority:	Taiwan: Department of Health

Keywords provided by China Medical University, China:

myopia, auricular acupoint, atropine, RCT

Additional relevant MeSH terms:

Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013