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Clinical Trials/NCT02784132
NCT02784132CompletedNot Applicable

Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial

University of British Columbia1 site in 1 country101 target enrollmentStarted: June 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
101
Locations
1
Primary Endpoint
Success rate of visualizing the optic disc within 60 seconds

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Year to 4 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes

Exclusion Criteria

  • •Patients who were blind, younger than 1 year of age, or older than 4 years of age

Arms & Interventions

Study Arm A

Other

Right eye examined first with video diversion then left eye examined without video diversion

Intervention: Video diversion (Other)

Study Arm B

Other

Right eye examined first without video diversion then left eye examined with video diversion

Intervention: Video diversion (Other)

Study Arm C

Other

Left eye examined first with video diversion then right eye examined without video diversion

Intervention: Video diversion (Other)

Study Arm D

Other

Left eye examined first without video diversion then right eye examined with video diversion

Intervention: Video diversion (Other)

Outcomes

Primary Outcomes

Success rate of visualizing the optic disc within 60 seconds

Time Frame: 60 second

Secondary Outcomes

  • Time required to visualize the optic disc(60 seconds)
  • Ease of performing fundoscopy(60 seconds)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ash Singhal

principal investigator

University of British Columbia

Study Sites (1)

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