Community Intervention and Demonstration Area Construction

Study Overview
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Brief Summary
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The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions. Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application. In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.

Official Title
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Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent

Conditions
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Myopia, Refractive Errors

Intervention / Treatment
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* Other: Six interventions for children and adolescents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ● Kindergarten kids. Grade of 1 to 6 in elementary schools. Grade of 1 to 3 in middle schools. Grade of 1 to 3 in high schools. Sign the informed consent. Exclusion Criteria: ●Visual defect or other eye diseases. wearing orthokeratology; refractive surgery history. Not considered suitable for inclusion in the study by the investigator.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cluster A<br>The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years. | Other: Six interventions for children and adolescents<br>* Vision Health Record Establishment and Myopia Risk Assessment. Evaluation of vision care behavior and development of reasonable eye use behavior. Health education for teachers and parents. Action to improve the reading and writing environment at home and school. One hour of outdoor activities in and out of school during the day. Myopia grading management and medical correction action.<br>|
| Experimental: Cluster B<br>The study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years. | Other: Six interventions for children and adolescents<br>* Vision Health Record Establishment and Myopia Risk Assessment. Evaluation of vision care behavior and development of reasonable eye use behavior. Health education for teachers and parents. Action to improve the reading and writing environment at home and school. One hour of outdoor activities in and out of school during the day. Myopia grading management and medical correction action.<br>|
| Experimental: Cluster C<br>The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year. | Other: Six interventions for children and adolescents<br>* Vision Health Record Establishment and Myopia Risk Assessment. Evaluation of vision care behavior and development of reasonable eye use behavior. Health education for teachers and parents. Action to improve the reading and writing environment at home and school. One hour of outdoor activities in and out of school during the day. Myopia grading management and medical correction action.<br>|
| Experimental: Cluster D<br>The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed. | Other: Six interventions for children and adolescents<br>* Vision Health Record Establishment and Myopia Risk Assessment. Evaluation of vision care behavior and development of reasonable eye use behavior. Health education for teachers and parents. Action to improve the reading and writing environment at home and school. One hour of outdoor activities in and out of school during the day. Myopia grading management and medical correction action.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in questionnaire survey | Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents. | Baseline, 6 months, 1 year, 1.5 years, 2 years | 
| Changes in uncorrected vision within two years | Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases)．All the measurements were recorded. | Baseline, 6 months, 1 year, 1.5 years, 2 years | 
| Changes in visual acuity in computer optometry | Optometry Automated computerized optometry is performed by an optometrist. Automatic optometry instrument using desktop computer automatic optometry, equipment requirements should conform to the ISO10342-2010 Ophthalmic instruments: Optometry provisions. | Baseline, 6 months, 1 year, 1.5 years, 2 years | 
| Changes in visual acuity during dilated pupil optometry | Between 5% and 10% of the participants were selected for Dilated pupil optometry. | Baseline, 6 months, 1 year, 1.5 years, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye protection diary | Daily questionnaire based on the development of myopia prevention and control in children and adolescents. | Three months. | 
| Qualitative interview | Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated. | Baseline, 1 year, 2 years |