Community Intervention and Demonstration Area Construction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Other: Six interventions for children and adolescents

• Study Type: Interventional
• Enrollment (Estimated): 1000000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FangBiao Tao, Professor; Phone Number: +86 19966513010; Email: vipur8@outlook.com

Study Locations

• China
  • Anhui
    • Anqing, Anhui, China, 246000
      • Recruiting
      • Anqing myopia scene
      • Contact: XiangLin Zhang; Phone Number: 19966513010; Email: 1696061680@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cluster A; 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; 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.
Experimental: Cluster B; 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; 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.
Experimental: Cluster C; 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; 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.
Experimental: Cluster D; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

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

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Collaborators: Shanghai Eye Disease Prevention and Treatment Center; Beijing Center for Disease Control and Prevention
• Investigators: Study Director: FangBiao Tao, Professor, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 20210735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No