the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

Myopia Clinical Trial

Official title:

the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055378
• Other study ID #: 99-IRB-032-XD
• Status: Completed
• Phase: N/A
• First received: February 2, 2014
• Last updated: February 3, 2014
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those treated with atropine alone.

Description:

Myopia has been an increasing problem among school children, especially in Asian countries. High myopia is not only a refractive problem, but also a disease that can result in a number of sight-threatening complications such as macular degeneration, retinal detachment, glaucoma, and cataract. Atropine is a long-acting non-selective muscarinic antagonist that blocks accommodation by paralyzing ciliary muscles; it may affect remodeling of the sclera and suppress the elongation of axial length. Acupuncture and acupressure have been widely used in traditional Chinese medicine for thousands of years. Auricular acupoint stimulation by acupuncture or acupressure has been reported to improve visual acuity in myopic patients. Therefore, we want to compare the effect of myopia control between patients treated with low-concentration atropine eye drops combined with auricular acupoint stimulation and those who treated with atropine alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children aged from 6 to 12 years with myopia, defined as spherical equivalent (SE) of -0.5 diopter (D) or less, were recruited from the outpatient clinics from January 2011 to June 2012.

Exclusion Criteria:

• (1) abnormal IOP (>21 mmHg) at presentation, (2) astigmatism or anisometropia of more than 1.5 D, (3) amblyopia or strabismus, (4) the presence of any related eyelid diseases, ocular diseases, or auricular diseases, (5) the presence of hemostatic disorders or other related major systemic diseases, (6) history of allergy to atropine, (7) previous or current use of contact lenses, bifocals, progressive lenses, or other forms of treatment for myopia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• Atropine
topical 0.125% atropine eye drops

Device:
• auricular acupoint stimulation
Five auricular acupoints (Shenmen, Xin, Yan, Mu 1 and Mu 2) Tapping stimulation was administered by using a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan) three times a day, each time for five minutes.

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Taipei	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in spherical equivalent (SE)	We measured the myopic progression (change in SE) of all the participants for at least six months.	SE measured at 3, 6, 9, 12 months.	No
Secondary	axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP)	We measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months.	AL, ACD, and IOP measure at 3, 6, 9, 12 months	No