Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression

NCT ID: NCT04017234

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-08-30

Brief Summary

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In Taiwan, the increasing prevalence of myopia shows a decline with age. Myopia has become a serious ocular problem in children because high myopia may lead to retinal damage, cataract and glaucoma. A prevention of myopia progression (PMP) will be developed and examined. This promotion program includes strategies such as a frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on the prevention of myopia progression. Eye exercise defined as a computerized image led motion. The study aims to examine the effect of the implementation on the PMP.

Detailed Description

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This is an experimental study. A sample size of 25\~40 participants from an elementary school will be recruited in the randomized controlled study.The sequential arrangement is arranged in a random manner for the participating children. A investigation of four groups will be designed for the PMP: Group 1 (frequency following response, Group 2(frequency following response,and eye exercise), Group 3 (frequency following response, eye exercise, transcutaneous electrical nerve stimulation and stimulating auricular acupoints), and Group 4, the control group. The PMP implement a 30 minute intervention two times per the investigators. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out. The duration of each intervention is provided for two days. The washout period following next intervention is 7 days at least. After completing four intervention, the effect of the best intervention of eight the investigator will be conducted.The evaluation time of the interventions will be observed at first-time and one-month observations. A descriptive and inferential statistics by SpSS will be used for data analysis.

The investigators will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on PMP among Taiwan schoolchildren. The findings of the study may provide information for promotion of visual health for schoolchildren and their parents.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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PMP group

children received health education for eye and the intervention(which included frequency following response, eye exercise, and transcutaneous electrical nerve stimulation) a 30 minute three times per week for four weeks.

Group Type EXPERIMENTAL

frequency following response, eye exercise, and transcutaneous

Intervention Type OTHER

frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks

control group

children just received health education for eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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frequency following response, eye exercise, and transcutaneous

frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* myopia is defined as the equivalent spherical surface degree of any one is less than or equal to -0.50D
* do not use cyclogel or atropine
* At least the eye ointment is deactivated for at least seven days
* no plastic tablets are currently used
* at least the plastic tablets are not allowed to be retired for more than seven days

Exclusion Criteria

* Children with current traumatic and unrecoverable other eye disease
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Kuei Teng

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Locations

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Chen Pin elementary school

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Kuei Teng

Role: CONTACT

886-4-22053366 ext. 7132

Facility Contacts

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Yu-Kuei Teng, PhD

Role: primary

886-4-22053366 ext. 7132

Shin-Da Lee, PhD

Role: backup

886-4-22053366 ext. 7300

Other Identifiers

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CMUH107-REC1-124

Identifier Type: -

Identifier Source: org_study_id

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