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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
September 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2020
CompletedMay 13, 2020
May 1, 2020
9 months
July 10, 2019
May 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
eyeball structure
eyeball diopter detection
one month detection after intervention
Secondary Outcomes (1)
vision check
one month detection after intervention
Study Arms (2)
PMP group
EXPERIMENTALchildren 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.
control group
NO INTERVENTIONchildren just received health education for eye
Interventions
frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Children with current traumatic and unrecoverable other eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chen Pin elementary school
Taichung, 406, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Kuei Teng
China Medical University, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2019
First Posted
July 12, 2019
Study Start
September 10, 2019
Primary Completion
May 30, 2020
Study Completion
August 30, 2020
Last Updated
May 13, 2020
Record last verified: 2020-05