Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 9:21 AM
Study NCT ID:
NCT01942057
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Prevalence in Canadian School Children - a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-16', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-09-09', 'lastUpdatePostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children with spherical equivalent refraction of at least -0.50D in at least one eye', 'timeFrame': 'Day1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cclr.uwaterloo.ca/', 'label': 'Centre for Contact Lens Research Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to determine the prevalence of nearsightedness in Canadian school children living in the Waterloo Region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'School children in Waterloo Region', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n* 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)\n* Is currently in school grades 1 and 2, 6 and 7 or 11 and 12\n* Is willing and able to follow instructions and maintain the appointment schedule\n\nExclusion Criteria:\n\n* Has not given verbal assent to participate\n* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study\n* Has undergone refractive error surgery or orthokeratology\n* Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests'}, 'identificationModule': {'nctId': 'NCT01942057', 'acronym': 'Falcon', 'briefTitle': 'Myopia Prevalence in Canadian School Children - a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'Myopia Prevalence in Canadian School Children - a Pilot Study', 'orgStudyIdInfo': {'id': '19043'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'School Grades 1+2', 'description': 'Children currently enrolled in grades 1 and 2'}, {'label': 'School Grades 6+7', 'description': 'Children currently enrolled in grades 6 and 7'}, {'label': 'School Grades 11+12', 'description': 'Children currently enrolled in grades 11 and 12'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Contact Lens Research', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'Lyndon Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Contact Lens Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}