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Falcon: Myopia Prevalence in Canadian School Children - a Pilot Study

Sponsor
University of Waterloo (Other)
Overall Status
Completed
CT.gov ID
NCT01942057
Collaborator
(none)
173
Enrollment
1
Location
16
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    173 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Myopia Prevalence in Canadian School Children - a Pilot Study
    Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Apr 1, 2015
    Actual Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    School Grades 1+2

    Children currently enrolled in grades 1 and 2
    School Grades 6+7

    Children currently enrolled in grades 6 and 7
    School Grades 11+12

    Children currently enrolled in grades 11 and 12

    Outcome Measures

    Primary Outcome Measures

    1. Number of children with spherical equivalent refraction of at least -0.50D in at least one eye [Day1]

    Eligibility Criteria

    Criteria

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

    • Has had a parent/legal guardian read the study consent form and who agrees to allow them to participate in the study by signing the consent form

    • Has had the "letter of assent for children" explained to them, the child has agreed to participate and the letter has been signed by the study investigator and the child

    • Has provided the completed Questionnaire (Appendix 4A for parents to complete on behalf of their children in school grades 1 and 2, 6 and 7; Appendix 4B for children to complete that are in school grades 11 and 12)

    • Is currently in school grades 1 and 2, 6 and 7 or 11 and 12

    • Is willing and able to follow instructions and maintain the appointment schedule

    Exclusion Criteria:

    • Has not given verbal assent to participate

    • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

    • Has undergone refractive error surgery or orthokeratology

    • Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Contact Lens Research Waterloo Ontario Canada N2L3G1

    Sponsors and Collaborators

    • University of Waterloo

    Investigators

    • Principal Investigator: Lyndon Jones, PhD, Center for Contact Lens Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Waterloo
    ClinicalTrials.gov Identifier:
    NCT01942057
    Other Study ID Numbers:
    • 19043
    First Posted:
    Sep 13, 2013
    Last Update Posted:
    Jul 20, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Jul 20, 2015