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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 15, 2014
Last verified: May 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

Resource links provided by NLM:


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: September 2014
Estimated Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 15, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Myopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 27, 2014