Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-03 @ 11:31 AM
Study NCT ID:
NCT02784132
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Diversion Improves Success Rate of Fundoscopic Examination in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-24', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of visualizing the optic disc within 60 seconds', 'timeFrame': '60 second'}], 'secondaryOutcomes': [{'measure': 'Time required to visualize the optic disc', 'timeFrame': '60 seconds'}, {'measure': 'Ease of performing fundoscopy', 'timeFrame': '60 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fundoscopy']}, 'referencesModule': {'references': [{'pmid': '29681489', 'type': 'DERIVED', 'citation': 'Yang MMH, Singhal A, Hengel AR, Kerr JM, St-Pierre GH, George S, Muir K, Thiessen P, Enarson P. Video Diversion Improves Success Rate of Fundoscopic Examination in Children: A Prospective Randomized Controlled Trial. Pediatr Neurol. 2018 Jun;83:32-37. doi: 10.1016/j.pediatrneurol.2017.09.008. Epub 2017 Sep 14.'}]}, 'descriptionModule': {'briefSummary': 'Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.', 'detailedDescription': 'Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy. The authors plan to recruit from 4 different clinical care settings for a total of 101 subjects. Success rate is defined as visualizing the optic disc within 60 seconds from commencement of fundoscopy. The ease of examination is determined by using a 10 point likert scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes\n\nExclusion Criteria:\n\n* Patients who were blind, younger than 1 year of age, or older than 4 years of age'}, 'identificationModule': {'nctId': 'NCT02784132', 'briefTitle': 'Video Diversion Improves Success Rate of Fundoscopic Examination in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H12-02053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Arm A', 'description': 'Right eye examined first with video diversion then left eye examined without video diversion', 'interventionNames': ['Other: Video diversion']}, {'type': 'OTHER', 'label': 'Study Arm B', 'description': 'Right eye examined first without video diversion then left eye examined with video diversion', 'interventionNames': ['Other: Video diversion']}, {'type': 'OTHER', 'label': 'Study Arm C', 'description': 'Left eye examined first with video diversion then right eye examined without video diversion', 'interventionNames': ['Other: Video diversion']}, {'type': 'OTHER', 'label': 'Study Arm D', 'description': 'Left eye examined first without video diversion then right eye examined with video diversion', 'interventionNames': ['Other: Video diversion']}], 'interventions': [{'name': 'Video diversion', 'type': 'OTHER', 'description': 'The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.', 'armGroupLabels': ['Study Arm A', 'Study Arm B', 'Study Arm C', 'Study Arm D']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Ash Singhal, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}