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Community Intervention and Demonstration Area Construction

Primary Purpose

Myopia, Refractive Errors

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Six interventions for children and adolescents
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Anqing myopia sceneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cluster A

Cluster B

Cluster C

Cluster D

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in questionnaire survey
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
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.
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.
Changes in visual acuity during dilated pupil optometry
Between 5% and 10% of the participants were selected for Dilated pupil optometry.

Secondary Outcome Measures

Eye protection diary
Daily questionnaire based on the development of myopia prevention and control in children and adolescents.
Qualitative interview
Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.

Full Information

First Posted
November 10, 2022
Last Updated
February 8, 2023
Sponsor
Anhui Medical University
Collaborators
Shanghai Eye Disease Prevention and Treatment Center, Beijing Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05715424
Brief Title
Community Intervention and Demonstration Area Construction
Official Title
Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University
Collaborators
Shanghai Eye Disease Prevention and Treatment Center, Beijing Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cluster A
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster B
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster C
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Six interventions for children and adolescents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in questionnaire survey
Description
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
Time Frame
Baseline, 6 months, 1 year, 1.5 years, 2 years
Title
Changes in uncorrected vision within two years
Description
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.
Time Frame
Baseline, 6 months, 1 year, 1.5 years, 2 years
Title
Changes in visual acuity in computer optometry
Description
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.
Time Frame
Baseline, 6 months, 1 year, 1.5 years, 2 years
Title
Changes in visual acuity during dilated pupil optometry
Description
Between 5% and 10% of the participants were selected for Dilated pupil optometry.
Time Frame
Baseline, 6 months, 1 year, 1.5 years, 2 years
Secondary Outcome Measure Information:
Title
Eye protection diary
Description
Daily questionnaire based on the development of myopia prevention and control in children and adolescents.
Time Frame
Three months.
Title
Qualitative interview
Description
Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.
Time Frame
Baseline, 1 year, 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FangBiao Tao, Professor
Phone
+86 19966513010
Email
vipur8@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FangBiao Tao, Professor
Organizational Affiliation
Anhui Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Anqing myopia scene
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XiangLin Zhang
Phone
19966513010
Email
1696061680@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Community Intervention and Demonstration Area Construction

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