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

The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren

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.

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Other: frequency following response, eye exercise, and transcutaneous

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 Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Kuei Teng; Phone Number: 7132 886-4-22053366; Email: tengyk@mail.cmu.edu.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 406
    • Recruiting
    • Chen Pin elementary school
    • Contact: Yu-Kuei Teng, PhD; Phone Number: 7132 886-4-22053366; Email: tengyk@mail.cmu.edu.tw
    • Contact: Shin-Da Lee, PhD; Phone Number: 7300 886-4-22053366; Email: shinda@mail.cmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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: control group; children just received health education for eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eyeball structure	eyeball diopter detection	one month detection after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vision check	Sellen's vision chart	one month detection after intervention

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Yu-Kuei Teng, China Medical University, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2019
• Primary Completion (ANTICIPATED): May 30, 2020
• Study Completion (ANTICIPATED): August 30, 2020

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CMUH107-REC1-124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No