Community Intervention and Demonstration Area Construction

NCT05715424 | Recruiting

• 1 other identifier: 20210735
• Study Type: interventional
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Eye protection diary

  Three months.

• Qualitative interview

  Baseline, 1 year, 2 years

Study Arms (4)

Cluster A

EXPERIMENTAL

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

Cluster B

EXPERIMENTAL

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

Cluster C

EXPERIMENTAL

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

Cluster D

EXPERIMENTAL

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

Interventions

Six interventions for children and adolescents 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 A; Cluster B; Cluster C; Cluster D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ● 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.

You may not qualify if:

• ●Visual defect or other eye diseases.
• wearing orthokeratology; refractive surgery history.

Sponsors & Collaborators

• Anhui Medical University: lead
• Shanghai Eye Disease Prevention and Treatment Center: collaborator
• Beijing Center for Disease Control and Prevention: collaborator

Study Sites (1)

Anqing myopia scene

Anqing, Anhui, 246000, China

RECRUITING

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• FangBiao Tao, Professor

  Anhui Medical University

  STUDY DIRECTOR

Central Study Contacts

FangBiao Tao, Professor

CONTACT

+86 19966513010; vipur8@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean, Anhui Medical University

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: February 8, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)