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Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457717
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
China Medical University, China
  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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


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:

  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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00457717     History of Changes
Other Study ID Numbers: DMR94-IRB-49
First Submitted: April 5, 2007
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
Last Verified: April 2007

Keywords provided by China Medical University, China:
myopia, auricular acupoint, atropine, RCT

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia 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