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Explore the efficacy of eye-transcutanclus electrical acupoint stimulation (Eye-TEAS) in delaying the early onset of myopia in children with pre-myopia

Registration number：

ITMCTR2024000193

Date of Last Refreshed on：

2024-08-07

Date of Registration：

2024-08-07

Registration Status：

Retrospective registration

Public title：

Explore the efficacy of eye-transcutanclus electrical acupoint stimulation (Eye-TEAS) in delaying the early onset of myopia in children with pre-myopia

English Acronym：

Scientific title：

Explore the efficacy of eye-transcutanclus electrical acupoint stimulation (Eye-TEAS) in delaying the early onset of myopia in children with pre-myopia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

jiang wenjun

Study leader：

bi hongsheng

Applicant telephone：

+86 184 5318 3883

Study leader's telephone：

+86 139 5311 3696

Applicant Fax：

Study leader's fax：

Applicant E-mail：

jiayingzhi8410@126.com

Study leader's E-mail：

hongshengbi@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

48 Yingxiong Shan Road, Shizhong District, Jinan City, Shandong Province

Study leader's address：

48 Yingxiong Shan Road, Shizhong District, Jinan City, Shandong Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

HEC-KS-2020003KY

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Eye Hospital Affiliated to Shandong University of Chinese Medicine

Date of approved by ethic committee：

2020/6/27 0:00:00

Contact Name of the ethic committee：

Li xiaopeng

Contact Address of the ethic committee：

48 Yingxiong Shan Road, Shizhong District, Jinan City, Shandong Province

Contact phone of the ethic committee：

+86 15066656303

Contact email of the ethic committee：

semkyk@126.com

Primary sponsor：

Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Primary sponsor's address：

Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Secondary sponsor：

Country：

China

Province：

shandong

City：

jinan

Institution
hospital：

Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Address：

48 Yingxiong Shan Road, Shizhong District, Jinan City, Shandong Province

Source(s) of funding：

National Key Research and Development Program

Target disease：

Pre-myopia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

To evaluate the efficacy of Eye-transcutanclus electrical acupoint stimulation (Eye-TEAS) for delaying the onset of myopia in children with pre-myopia aged 6-12 years.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

The inclusion criteria included 1) children with age 6 to 12 years old, 2)uncorrected visual acuity (UCVA) of ≤0.0 logMAR, a cycloplegic spherical equivalent refraction (SER) of >-0.50 diopter (D) and ≤+0.75 D, anisometropia of ≤1.50 D. Written informed consent was obtained from all participants' parents or legal guardians.

Exclusion criteria：

Children were excluded if they had currently or previously accepted any other interventions for myopia, including ① atropine eye drops and orthokeratology, or had serious systemic diseases, ② psychiatric disorders, ③ an allergy to medical silica gel ④ children with amblyopia, strabismus, corneal scar, cataract, glaucoma, ocular tumour, or other eye diseases were also excluded.

Study execute time：

From 2020-07-01

To      2020-12-14

Recruiting time：

From 2020-07-01

To      2020-07-20

Interventions：

85

Group：

Sham-TEAS group

Sample size：

Intervention：

sham- Eye-TEAS

Intervention code：

85

Group：

TEAS group

Sample size：

Intervention：

Eye-TEAS

Intervention code：

Total sample size ： 170

Countries of recruitment
and research settings：

Country：

China

Province：

Shan dong

City：

Jinan

Institution/hospital：

Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Level of the institution：

Third class first class

Outcomes：

Outcome：

The incidence rate of myopia

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change of axial length

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

The change of spherical equivalent refraction

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

None

Tissue：

None

Fate of sample 

Others

Note：

Completed

6
Min age years
12
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Pre-myopia children aged 6 to 12 years were divided into the Eye-TEAS group and the false Eye-TEAS group by random number table method

Blinding：

Researchers, participants, and their parents were blinded, and optometrists, outcome evaluators, and statisticians were kept blind during the trial.

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The raw data will be made public by publishing an attachment to the article, after published.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data were captured and recorded through the CRF form, and a two-person entry verification process was used to enter the information from the CRF form into an EXCEL spreadsheet.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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