Clinical trial NCT00457717: Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: myopia, auricular acupoint, atropine, RCT
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: the progression of myopia degree, axial length elongation of eye
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, Taiwan
name: Shih-Liang Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/00006324-198210000-00010.
citation: 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.
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. doi: 10.1016/s0161-6420(01)00972-1.
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. doi: 10.1089/jop.1999.15.85.
citation: Chen MC. 112 cases of juvenile myopia treated by auricular acupressure. J Tradit Chin Med. 1989 Sep;9(3):173. No abstract available.
citation: 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.