Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

NCT00457717 | Completed Phase 1 DMC

• 1 other identifier: DMR94-IRB-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia, auricular acupoint, atropine, RCT

Outcome Measures

Primary Outcomes (1)

• the progression of myopia degree, axial length elongation of eye

Interventions

0.25 % atropine DRUG

0.5 % atropine DRUG

0.25 % atropine+auricular acupoints PROCEDURE

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

China Medical University

Taichung, Taiwan

Location

Related Publications (6)

• 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. doi: 10.1097/00006324-198210000-00010.

  PMID: 7148977 BACKGROUND

• 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.

  PMID: 15008558 BACKGROUND

• 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. doi: 10.1016/s0161-6420(01)00972-1.

  PMID: 11874738 BACKGROUND

• 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. doi: 10.1089/jop.1999.15.85.

  PMID: 10048351 RESULT

• Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. No abstract available.

  PMID: 2615447 RESULT

• Liang CK, Ho TY, Li TC, Hsu WM, Li TM, Lee YC, Ho WJ, Cheng JT, Tzeng CY, Liu IT, Chang SL. A combined therapy using stimulating auricular acupoints enhances lower-level atropine eyedrops when used for myopia control in school-aged children evaluated by a pilot randomized controlled clinical trial. Complement Ther Med. 2008 Dec;16(6):305-10. doi: 10.1016/j.ctim.2008.04.007. Epub 2008 May 29.

  PMID: 19028329 DERIVED

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Shih-Liang Chang, PhD

  China Medical University, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2007
• First Posted: April 6, 2007
• Study Start: July 1, 2005
• Study Completion: July 1, 2006
• Last Updated: April 6, 2007

Record last verified: 2007-04

Locations

TW (1)