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NCT01942057 Clinical Trial

Myopia Prevalence in Canadian School Children - a Pilot Study

Myopia Clinical Trial

— Falcon  

Official title:
Myopia Prevalence in Canadian School Children - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01942057
Other study ID # 19043
Secondary ID
Status Completed
Phase N/A
First received August 21, 2013
Last updated July 16, 2015
Start date December 2013
Est. completion date April 2015

Study information
Verified date July 2015
Source University of Waterloo
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review CommitteeCanada: Health Canada
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 173
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 18 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Centre for Contact Lens Research Waterloo Ontario

Sponsors (1)
Lead Sponsor Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of children with spherical equivalent refraction of at least -0.50D in at least one eye Day1 No
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