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CompletedNCT02055378Updated Feb 5, 2014

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

An interventional study of Atropine and auricular acupoint stimulation in Myopia, sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation. Completed at 1 site in Taiwan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2014-02-05.

Sponsored by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Myopia

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Keywords

  • myopia
  • atropine
  • anterior chamber depth
  • auricular acupoint
  • axial length
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 73 is close to the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation is the lead sponsor of 55 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
73 participants (actual)

Study arms

  • Experimental
    auricular acupoint stimulation

    Five auricular acupoints were selected for taping stimulation by using a 1-mm alloy ball by fingers three times a day, each time for five minutes over the five selected acupoints. Topical 0.125% atropine was given nightly.

    Drug: Atropine · Device: auricular acupoint stimulation

  • Active comparator
    Atropine

    topical 0.125% atropine was given nightly during the study period.

    Drug: Atropine

Interventions

  • DrugAtropine

    topical 0.125% atropine eye drops

    Also known as: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

  • Deviceauricular 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.

    Also known as: a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)

06

What researchers measure

Primary outcomes

  1. the change in spherical equivalent (SE)

    We measured the myopic progression (change in SE) of all the participants for at least six months.

    Time frame: SE measured at 3, 6, 9, 12 months.

Secondary outcomes

  1. 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.

    Time frame: AL, ACD, and IOP measure at 3, 6, 9, 12 months

07

Study locations

1 site
  • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    Taipei, New Taipei City 231, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02055378
Lead sponsor
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Responsible party
Sponsor
First posted
Feb 5, 2014
Start date
Jan 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 5, 2014

Study contacts

Liao, MD
study chair · Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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