Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02055378
Enrollment
73
Registered
2014-02-05
Start date
2011-01-31
Completion date
2012-12-31
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

myopia, atropine, anterior chamber depth, auricular acupoint, axial length

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.

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.

Interventions

DRUGAtropine

topical 0.125% atropine eye drops

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.

Sponsors

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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

* (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.

Design outcomes

Primary

MeasureTime frameDescription
the change in spherical equivalent (SE)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

MeasureTime frameDescription
axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP)AL, ACD, and IOP measure at 3, 6, 9, 12 monthsWe measured the axial length (AL) elongation, anterior chamber depth (ACD) and intraocular pressure(IOP) of all the participants for at least six months.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026