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Correlation Between Refraction and Biometric Parameters

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04346251
Collaborator
(none)
1,000
Enrollment
1
Location
37
Anticipated Duration (Months)
27
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlation Analysis of Refraction and Biometric Parameters in Chinese Schoolchildren
    Actual Study Start Date :
    Nov 1, 2017
    Actual Primary Completion Date :
    Nov 30, 2019
    Anticipated Study Completion Date :
    Dec 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. refractive error in diopters and biometric Parameters [up to 1 year]

      Multiple regression analysis will be performed to evaluate the correlations between SER and the other biometric parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Schoolchildren aged from 6 to 15 years
    Exclusion Criteria:

    • with previous histories of cataracts, keratitis, strabismus, or other visual impairments

    • with history of previous eye surgery

    • with unreliable auto-refraction values

    • unwilling to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhognshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haotian Lin, Principal Investigator, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04346251
    Other Study ID Numbers:
    • CCPMOH2017-China-1101
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Apr 15, 2020
    Last Verified:
    Apr 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Apr 15, 2020