Community Intervention and Demonstration Area Construction

NCT ID: NCT05715424

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Myopia; Refractive Errors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Six interventions for children and adolescents

Intervention Type: OTHER

• 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.

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.

Group Type: EXPERIMENTAL

Six interventions for children and adolescents

Intervention Type: OTHER

• 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.

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.

Group Type: EXPERIMENTAL

Six interventions for children and adolescents

Intervention Type: OTHER

• 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.

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.

Group Type: EXPERIMENTAL

Six interventions for children and adolescents

Intervention Type: OTHER

• 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: collaborator

Beijing Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fangbiao Tao

Professor and Dean, Anhui Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FangBiao Tao, Professor

Role: STUDY_DIRECTOR

Anhui Medical University

Locations

Anqing myopia scene

Anqing, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

FangBiao Tao, Professor

Role: CONTACT

vipur8@outlook.com

+86 19966513010

Facility Contacts

XiangLin Zhang

Role: primary

1696061680@qq.com

19966513010

Other Identifiers

20210735

Identifier Type: -

Identifier Source: org_study_id