The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

Study Overview
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Brief Summary
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The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

Detailed Description
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The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Official Title
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The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

Conditions
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Myopia, High Myopia

Intervention / Treatment
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* Behavioral: Home training
* Behavioral: School training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All students in grades 1 to 4 Can cooperate with the examination of students Exclusion Criteria: Obvious strabismus and amblyopia Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases History of ocular surgery

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-school training group<br>There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time. | Behavioral: Home training<br>* Letter Chart Accomodative Rock Training for 2 minutes each time<br>Behavioral: School training<br>* Letter Chart Accomodative Rock Training for 2 minutes each time<br>|
| Experimental: School training group<br>There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time. | Behavioral: School training<br>* Letter Chart Accomodative Rock Training for 2 minutes each time<br>|
| No Intervention: No training group<br>There was no such treatment for students. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of new-onset myopia | The number of new children with myopia was counted | Through study completion, an average of 1 year | 
| The changes of refractive error | The changes of refractive error between visit time and baseline which was obtained with a computer refractometer. | Every 6 months, up to 3 years | 
| The changes of axial length | The axial length was measured by a biological measuring instrument. | Every 6 months, up to 3 years |