Myopia Prevalence in Canadian School Children - a Pilot S... | NCT01942057

Studies
Myopia Prevalence in Canadian School Children - a Pilot Study

NCT01942057

Sponsor

University of Waterloo

Status

Completed

Last Update Posted

Jul 20, 2015Estimated

Enrollment

173Actual

Phase

Not provided

Conditions

Myopia

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Aug 21, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2015

Last Update Posted Date

Jul 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of children with spherical equivalent refraction of at least -0.50D in at least one eye		Day1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

School children in Waterloo Region

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lyndon Jones, PhD	Center for Contact Lens Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Contact Lens Research		Waterloo	Ontario	N2L3G1	Canada

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases