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临床试验/NCT04017234
NCT04017234Unknown不适用

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

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
27
试验地点
2
主要终点
eyeball structure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Children with current traumatic and unrecoverable other eye disease

结局指标

主要结局

eyeball structure

时间窗: one month detection after intervention

eyeball diopter detection

次要结局

  • vision check(one month detection after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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