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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
  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:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional 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
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
Eye Diseases
Refractive Errors
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014