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Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05336799
Collaborator
(none)
500,000
Enrollment
1
Location
58
Anticipated Duration (Months)
8617.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The high prevalence of myopia has become a global public health problem. The study amied to investigate the prevalence and progression of myopia associated with social environmental factors in Tianjin, a Chinese megacity in north China.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The high prevalence of myopia has become a global public health problem, especially in East and South Asian countries. It's still not clear for the prevalence and progression of myopia associated with social environmental factors. Thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among Chinese school-aged children and adolescent.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Environmental Factors for Myopia Among Chinese School-aged Children and Adolescent in Tianjin
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of myopia [up to 3years]

      Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).

    Secondary Outcome Measures

    1. Changes in prevalence of myopia [up to 3years]

      Myopia is defined as any eye's SER (sphere + 1/2 cylinder) of at least -0.5 diopters (D).

    2. Changes of Spherical equivalent [changes from baseline at 36months]

      Changes of Spherical equivalent

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • aged 6 to 18 years

    • no ocular diseases and systemic diseases

    • consent to undergo an eye examination

    Exclusion Criteria:
    • schoolchildren unwilling to participate

    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 Chair: yan wang, Tianjin Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT05336799
    Other Study ID Numbers:
    • Tianjin Myopia Study
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2021
    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
    Keywords provided by Tianjin Eye Hospital
    Myopia
    Socioeconomics
    Additional relevant MeSH terms:
    Myopia
    Refractive Errors

    Study Results

    No Results Posted as of Apr 20, 2022