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

Not Applicable

• Conditions: Myopia
• Interventions: Other: frequency following response, eye exercise, and transcutaneous

• Registration Number: NCT04017234
• Lead Sponsor: China Medical University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Start: 2019-09-10
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13
• Primary Completion: 2020-05-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PMP group	frequency following response, eye exercise, and transcutaneous	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.

Primary Outcome Measures

Name	Time	Method
eyeball structure	one month detection after intervention	eyeball diopter detection

Secondary Outcome Measures

Name	Time	Method
vision check	one month detection after intervention	Sellen's vision chart

Trial Locations

Locations (1)

Chen Pin elementary school; 🇨🇳 Taichung, Taiwan