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

Primary Purpose

Myopia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
frequency following response, eye exercise, and transcutaneous
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chen Pin elementary schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PMP group

control group

Arm Description

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.

children just received health education for eye

Outcomes

Primary Outcome Measures

eyeball structure
eyeball diopter detection

Secondary Outcome Measures

vision check
Sellen's vision chart

Full Information

First Posted
July 10, 2019
Last Updated
May 11, 2020
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04017234
Brief Title
Eye Exercise, Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression
Official Title
The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PMP group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
children just received health education for eye
Intervention Type
Other
Intervention Name(s)
frequency following response, eye exercise, and transcutaneous
Intervention Description
frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks
Primary Outcome Measure Information:
Title
eyeball structure
Description
eyeball diopter detection
Time Frame
one month detection after intervention
Secondary Outcome Measure Information:
Title
vision check
Description
Sellen's vision chart
Time Frame
one month detection after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Kuei Teng
Phone
886-4-22053366
Ext
7132
Email
tengyk@mail.cmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Kuei Teng
Organizational Affiliation
China Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chen Pin elementary school
City
Taichung
ZIP/Postal Code
406
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Kuei Teng, PhD
Phone
886-4-22053366
Ext
7132
Email
tengyk@mail.cmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Shin-Da Lee, PhD
Phone
886-4-22053366
Ext
7300
Email
shinda@mail.cmu.edu.tw

12. IPD Sharing Statement

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

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