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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055378
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Information provided by (Responsible Party):
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Myopia Drug: Atropine Device: auricular acupoint stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: the Effect of Low-Concentration Atropine Combined With Auricular Acupoint Stimulation in Myopia Control
Study Start Date : January 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
topical 0.125% atropine eye drops
Other Name: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)

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.
Other Name: a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan)

Active Comparator: Atropine
topical 0.125% atropine was given nightly during the study period.
Drug: Atropine
topical 0.125% atropine eye drops
Other Name: 0.125% atropine (Sinphar Pharmaceutical, Ilan, Taiwan)




Primary Outcome Measures :
  1. the change in spherical equivalent (SE) [ Time Frame: SE measured at 3, 6, 9, 12 months. ]
    We measured the myopic progression (change in SE) of all the participants for at least six months.


Secondary Outcome Measures :
  1. axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) [ Time Frame: AL, ACD, and IOP measure at 3, 6, 9, 12 months ]
    We measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055378


Locations
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Taiwan
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, New Taipei City, Taiwan, 231
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
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Study Chair: Liao, MD Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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Responsible Party: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT02055378    
Other Study ID Numbers: 99-IRB-032-XD
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: December 2012
Keywords provided by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
myopia
atropine
anterior chamber depth
auricular acupoint
axial length
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action