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

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ClinicalTrials.gov Identifier: NCT04017234
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:

In a nationwide survey 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 in the study. 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.

A sample size of 60~100 participants from an elementary school will be recruited in the randomized controlled study. Inclusion criteria are a child: (a) who has a myopia condition with the spherical equivalent objective refractive error is ≤ -0.50 diopter in either eye", (b) who did not take eye drop of atropine or cyclogel, (c) who did not take any drugs for eyes, (d) who did not wear orthokeratology lenses at least 7 days, (e)who can fill a questionnaire. Exclusion criteria include a child (a) who has any eye trauma or eye disorder.

This is an experimental 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 week. Pre-test and post-test (eyeball diopter detection and Sellen's vision chart) will be carried out for four intervention. 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 weeks will be conducted.

The evaluation time of the interventions will be observed at first-time and two-month observations. A descriptive and inferential statistics with a percentage, average, mean, standard derivation, and ANOVA by SpSS will be used for data analysis.

In the present study, we will apply the frequency following response, eye exercise, and transcutaneous electrical nerve stimulation on prevention of myopia progression among Taiwan schoolchildren. The findings of the study may provide useful information for promotion and prevention of visual health for schoolchildren and their parents.


Condition or disease Intervention/treatment Phase
Myopia Other: frequency following response, eye exercise, and transcutaneous Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effects of Frequency Following Response, Eye Exercise, and Transcutaneous Electrical Nerve Stimulation on Prevention of Myopia Progression in Taiwan Schoolchildren
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : July 20, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: frequency following response, eye exercise, and transcutaneous
frequency following response, eye exercise, and transcutaneous electrical nerve stimulation
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: No intervention



Primary Outcome Measures :
  1. eyeball diopter detection [ Time Frame: detection after intervention for one month ]

Secondary Outcome Measures :
  1. Sellen's vision chart [ Time Frame: detection after intervention for one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The conditions for selection are as follows: (1) myopia is defined as the equivalent spherical surface (SE) degree of any one is less than or equal to -0.50D; (2) is currently not used drugs of cyclogel, atropine (3) At least the eye ointment is deactivated for at least seven days; (4) no plastic tablets are currently used; (5) at least the plastic tablets are not allowed to be retired for more than seven days;

Exclusion Criteria:

  • Children with current (some) traumatic and unrecoverable other eye diseases

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04017234     History of Changes
Other Study ID Numbers: CMUH107-REC1-124
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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

Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases