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

April 5, 2007
April 5, 2007
July 2005
Not Provided
the progression of myopia degree, axial length elongation of eye
Same as current
No Changes Posted
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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
Not Provided

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Myopia
  • Drug: 0.25 % atropine
  • Drug: 0.5 % atropine
  • Procedure: 0.25 % atropine+auricular acupoints
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2006
Not Provided

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00457717
DMR94-IRB-49
Yes
Not Provided
China Medical University, China
Not Provided
Principal Investigator: Shih-Liang Chang, PhD China Medical University, Taiwan
China Medical University, China
April 2007

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