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Myopia Prevalence in Canadian School Children - a Pilot Study (Falcon)

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ClinicalTrials.gov Identifier: NCT01942057
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : July 20, 2015
Sponsor:
Information provided by (Responsible Party):
University of Waterloo

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
Myopia

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 : December 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Group/Cohort
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



Primary Outcome Measures :
  1. Number of children with spherical equivalent refraction of at least -0.50D in at least one eye [ Time Frame: Day1 ]


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
School children in Waterloo Region
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942057


Locations
Canada, Ontario
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

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01942057     History of Changes
Other Study ID Numbers: 19043
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases