MyopiaFalconNCT01942057
Myopia Prevalence in Canadian School Children - a Pilot Study
An observational study of Myopia, run by University of Waterloo at 1 site in Canada.
Trial summary
The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: School children in Waterloo Region
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.
- Conditions
- Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with spherical equivalent refraction of at least -0.50D in at least one eye
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, Principal investigator, Center for Contact Lens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942057
- Sponsor's protocol ID
- 19043
- Acronym
- Falcon
- Status last verified
- Jul 2015
- First submitted
- 21 Aug 2013
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Prevalence in Canadian School Children - a Pilot Study
- ClinicalTrials.gov ID
- NCT01942057
- Acronym / sponsor ID
- Falcon / 19043
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- School children in Waterloo Region
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of children with spherical equivalent refraction of at least -0.50D in at least one eye
Time frame: Day1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
- Centre for Contact Lens Research WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyndon Jones, PhD principal investigator
Center for Contact Lens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with spherical equivalent refraction of at least -0.50D in at least one eye (time frame: Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.