Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

• Sponsor: China Medical University, China (Other)
• Overall Status: Completed
• CT.gov ID: NCT00457717
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: 0.25 % atropine; Drug: 0.5 % atropine; Procedure: 0.25 % atropine+auricular acupoints	Phase 1

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2005
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. the progression of myopia degree, axial length elongation of eye []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5

1. 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

Locations

	Site	City	State	Country	Postal Code
1	China Medical University	Taichung City		Taiwan

Sponsors and Collaborators

• China Medical University, China

Investigators

• Principal Investigator: Shih-Liang Chang, PhD, China Medical University, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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 Singap. 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.

• ClinicalTrials.gov Identifier: NCT00457717
• Other Study ID Numbers: DMR94-IRB-49
• First Posted: Apr 6, 2007
• Last Update Posted: Apr 6, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: myopia, auricular acupoint, atropine, RCT
• Additional relevant MeSH terms: Myopia; Atropine

Study Results

No Results Posted as of Apr 6, 2007