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Community Intervention and Demonstration Area Construction

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05715424
Enrollment
1000000
Registered
2023-02-08
Start date
2022-12-01
Completion date
2024-12-31
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Refractive Errors

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.

Interventions

OTHERSix 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.

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
CollaboratorOTHER
Beijing Center for Disease Control and Prevention
CollaboratorOTHER_GOV
Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in questionnaire surveyBaseline, 6 months, 1 year, 1.5 years, 2 yearsQuestionnaires 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 yearsBaseline, 6 months, 1 year, 1.5 years, 2 yearsUncorrected 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 optometryBaseline, 6 months, 1 year, 1.5 years, 2 yearsOptometry 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 optometryBaseline, 6 months, 1 year, 1.5 years, 2 yearsBetween 5% and 10% of the participants were selected for Dilated pupil optometry.

Secondary

MeasureTime frameDescription
Eye protection diaryThree months.Daily questionnaire based on the development of myopia prevention and control in children and adolescents.
Qualitative interviewBaseline, 1 year, 2 yearsBased on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.

Countries

China

Contacts

Primary ContactFangBiao Tao, Professor
vipur8@outlook.com+86 19966513010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026