A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05967702
Collaborator
(none)
126,810
1
30
4223

Study Details

Study Description

Brief Summary

This is a school-based, cross-sectional study to assess the incidence and prevalence, risk factors of myopia among schoolchildren in both eye-use environment, eye-use habits, lifestyle, and family and subjective factors before and during COVID-19. Large population and representative study subjects. Environmental exposure and daily within and out-of-school activities will be evaluated in a random subgroup.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Myopia is the most common refractive error and a major reason for reducing uncorrected visual acuity among schoolchildren. It was reported that during COVID-19, home confinement resulted in a significant increase in myopia due to the changed lifestyle of schoolchildren dramatically. However, it is unclear which kind of risk factors should be the first to bear the brunt before and during COVID-19. And which factors should be emphasized and confronted as the optimum strategy for myopia prevention and control? This cohort study aims to determine the risk factors, prevalence, and incidence of myopia, and SE changes among schoolchildren before and during COVID-19, hence identifying the factors that impact the onset and progression of myopia.

    This is a 3-year cross-sectional study. This study plans to enroll 126,810 participants (aged 6-18 years) from Tianjin, China. All grade students from 10 regions of Tianjin City, China will be analyzed. Over a 3-year follow-up period, students will receive detailed eye examinations annually and complete questionnaires about eye-use environment, eye-use habits, lifestyle, and family and subjective factors. In a 5% random sample size of this cohort study, outdoor activity, light intensity, eye use habits, and eye use environment data will be obtained using objective measuring devices. Myopia was defined as spherical equivalent refractive (SER) of ≤ -0.5D.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    126810 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    A 3-year Cross-sectional Assessment of the Tianjin Child and Adolescent Large-scale Eye Study
    Actual Study Start Date :
    Jul 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of myopia [One day measurement]

      Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye

    2. Prevalence of high myopia [One day measurement]

      High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All 6-18 years students
    Exclusion Criteria:
    • No eye diseases such as cataracts, glaucoma, keratoconus, etc.

    • No psychiatric disorders

    • Astigmatism ≤ -6.00D

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Eye Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Eye Hospital

    Investigators

    • Study Director: Yan Wang, director, Tianjin Eye Hospital and Eye Institute, Nankai University Affiliated Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT05967702
    Other Study ID Numbers:
    • KY-2023040
    First Posted:
    Aug 1, 2023
    Last Update Posted:
    Aug 1, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 1, 2023