Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression
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|ClinicalTrials.gov Identifier: NCT04017234|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
In a nationwide survey 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 in the study. 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.
A sample size of 60~100 participants from an elementary school will be recruited in the randomized controlled study. Inclusion criteria are a child: (a) who has a myopia condition with the spherical equivalent objective refractive error is ≤ -0.50 diopter in either eye", (b) who did not take eye drop of atropine or cyclogel, (c) who did not take any drugs for eyes, (d) who did not wear orthokeratology lenses at least 7 days, (e)who can fill a questionnaire. Exclusion criteria include a child (a) who has any eye trauma or eye disorder.
This is an experimental 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 week. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out for four intervention. 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 weeks will be conducted.
The evaluation time of the interventions will be observed at first-time and two-month observations. A descriptive and inferential statistics with a percentage, average, mean, standard derivation, and ANOVA by SpSS will be used for data analysis.
In the present study, we will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on prevention of myopia progression among Taiwan schoolchildren. The findings of the study may provide useful information for promotion and prevention of visual health for schoolchildren and their parents.
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Other: frequency following response, eye exercise, and transcutaneous||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren|
|Estimated Study Start Date :||July 20, 2019|
|Estimated Primary Completion Date :||July 20, 2019|
|Estimated Study Completion Date :||November 30, 2019|
Experimental: frequency following response, eye exercise, and transcutaneous
frequency following response, eye exercise, and transcutaneous electrical nerve stimulation
Other: frequency following response, eye exercise, and transcutaneous
frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks
|No Intervention: No intervention|
- eyeball diopter detection [ Time Frame: detection after intervention for one month ]
- Sellen's vision chart [ Time Frame: detection after intervention for one month ]