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

This study is not yet open for participant recruitment.
Verified February 2014 by University of Waterloo
Sponsor:
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01942057
First received: August 21, 2013
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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


Condition
Myopia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Myopia Prevalence in Canadian School Children - a Pilot Study

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Number of children with spherical equivalent refraction of at least -0.50D in at least one eye [ Time Frame: Day1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942057

Contacts
Contact: Kathy Dumbleton, PhD 519 888 4567 ext 32694 kathy.dumbleton@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research Recruiting
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Investigators
Principal Investigator: Desmond Fonn, MOptom FAAO Center for Contact Lens Research
  More Information

Additional Information:
No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01942057     History of Changes
Other Study ID Numbers: 19043
Study First Received: August 21, 2013
Last Updated: February 24, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014