Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457717
• Other study ID #: DMR94-IRB-49
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2007
• Last updated: April 5, 2007
• Start date: July 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 0.25 % atropine

• 0.5 % atropine

Procedure:
• 0.25 % atropine+auricular acupoints

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung City

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. — View Citation

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. — View Citation

Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singapore. 2004 Jan;33(1):27-33. — View Citation

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. — View Citation

Shih YF, Chen CH, Chou AC, Ho TC, Lin LL, Hung PT. Effects of different concentrations of atropine on controlling myopia in myopic children. J Ocul Pharmacol Ther. 1999 Feb;15(1):85-90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the progression of myopia degree, axial length elongation of eye