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Clinical Trials/NCT05715424
NCT05715424
Recruiting
Not Applicable

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

Anhui Medical University1 site in 1 country1,000,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Anhui Medical University
Enrollment
1000000
Locations
1
Primary Endpoint
Changes in visual acuity in computer optometry
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Anhui Medical University
Responsible Party
Principal Investigator
Principal Investigator

Fangbiao Tao

Professor and Dean, Anhui Medical University

Anhui Medical University

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.

Outcomes

Primary Outcomes

Changes in visual acuity in computer optometry

Time Frame: Baseline, 6 months, 1 year, 1.5 years, 2 years

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 uncorrected vision within two years

Time Frame: Baseline, 6 months, 1 year, 1.5 years, 2 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 during dilated pupil optometry

Time Frame: Baseline, 6 months, 1 year, 1.5 years, 2 years

Between 5% and 10% of the participants were selected for Dilated pupil optometry.

Changes in questionnaire survey

Time Frame: Baseline, 6 months, 1 year, 1.5 years, 2 years

Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.

Secondary Outcomes

  • Eye protection diary(Three months.)
  • Qualitative interview(Baseline, 1 year, 2 years)

Study Sites (1)

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