Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

This study has been completed.

Sponsor:

Information provided by:

China Medical University, China

ClinicalTrials.gov Identifier:

NCT00457717

First received: April 5, 2007

Last updated: NA

Last verified: April 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

April 5, 2007

Last Updated Date

April 5, 2007

Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

the progression of myopia degree, axial length elongation of eye

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Drug: 0.25 % atropine
Drug: 0.5 % atropine
Procedure: 0.25 % atropine+auricular acupoints

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00457717

Other Study ID Numbers ^ICMJE

DMR94-IRB-49

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

China Medical University, China

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shih-Liang Chang, PhD

China Medical University, Taiwan

Information Provided By

China Medical University, China

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top