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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017234
• Other study ID #: CMUH107-REC1-124
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2020
• Source: China Medical University Hospital
• Contact: Yu-Kuei Teng
• Phone: 886-4-22053366
• Email: tengyk[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: August 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chen Pin elementary school	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eyeball structure	eyeball diopter detection	one month detection after intervention
Secondary	vision check	Sellen's vision chart	one month detection after intervention