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5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders

Sponsor
Universitaire Ziekenhuizen KU Leuven (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05612568
Collaborator
(none)
250,000
Enrollment
1
Location
12
Anticipated Duration (Months)
20847.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this research we will investigate the distribution and evolution of amblyopia risk factors and other refractive errors in children younger than 3 years of age. The significance and magnitude of current global evolutions in ARF and refractive errors will be verified to update current guidelines and practices. Better insight in associated factors of amblyopia risk factors will contribute to current understanding of amblyopia.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The eye screening program of the Flemish governmental agency 'Kind en Gezin' is a well-implemented screening program for detection of ARF in children under the age of 3 years. This screening covers almost 85% of all children born in the Flemish community. Valuable information about distribution and determinants of refractive errors and ARF are collected at 'Kind en Gezin', but remain unstudied until today.

    Our aim is to analyze the distribution and evolution of refractive errors in children under the age of 3 years in Flanders. We suppose that identification of patterns in this distribution, and identification of determinants that influence ARF, will lead to improved knowledge about amblyopia (risk factors) and on their turn help optimize the ARF screening program. Evaluation of the distribution and evolution of refractive errors over time, and comparison with global results, will also give us insight in the significance of the myopia epidemic in Flanders.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Five Years of Eye Screening for Amblyopia Risk Factors in Children Aged <3 Years in Flanders: Epidemiological Retrospective Study
    Actual Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Refractive error per eye [during single-visit screening]

      Sphere, cylinder, spherical equivalent

    2. Difference in refractive error between both eyes [during single-visit screening]

      Sphere OD-OS, cylinder OD-OS, spherical equivalent OD-OS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Months to 31 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • We include all children with a PlusOptix screening between 2013 and 2018 with the age of 12±1 months or 30±1 months. Children who were screened twice, can be included twice with both screening results.
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Belgium 3000

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen KU Leuven

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitaire Ziekenhuizen KU Leuven
    ClinicalTrials.gov Identifier:
    NCT05612568
    Other Study ID Numbers:
    • S64110
    First Posted:
    Nov 10, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Nov 1, 2022
    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:
    Amblyopia

    Study Results

    No Results Posted as of Nov 10, 2022