Video Diversion During Fundoscopic Exam in Children (CAFE)

Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial

Fundoscopy is an important aspect of the neurological examination, but can be challenging in uncooperative children. This study explored whether viewing a video (selected by patient or caregiver) during eye examination improves the success, duration and ease of pediatric fundoscopy.

Hypothesis: Showing a short video clip during a fundoscopic exam will increase the probability of successfully visualizing the optic disk and reduce the amount of time needed to perform a fundoscopic exam in children between 1-8 years old.

Study Overview

• Status: Completed
• Conditions: Other Disorders of Optic Disc, Bilateral
• Intervention / Treatment: Other: Video (played on a computer monitor)

Detailed Description

The purpose of this study is to examine whether showing a video clip with sound of the patient's choice can improve the ease of fundoscopic exam as defined by improved success of visualizing the optic disk and the reduction in time needed to perform the exam. The investigators will also examine the physician's and caregiver's perception on whether the video was effective in improving the ease of the exam. The purpose of the video is to capture the visual attention of the patient thereby allowing the physician to swiftly perform the fundoscopic exam. The literature has suggested that young patients are most uncooperative, therefore the investigators will focus our study on younger patients 1-8 years old.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • BC Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1-8 years old
• Capable of visualizing the video monitor
• Patient has 2 examinable eyes

Exclusion Criteria:

• Blind patient
• Patients < 1 or > 8 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1st: R eye video. 2nd: L eye no video; The right eye will be examined first with video, followed by the left eye without video.	Other: Video (played on a computer monitor); The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
Experimental: 1st: R eye no video. 2nd: L eye video; The right eye will be examined without video, followed by the left eye with video.	Other: Video (played on a computer monitor); The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
Experimental: 1st: L eye video. 2nd: R eye no video; The left eye will be examined first with video, followed by the right eye without video.	Other: Video (played on a computer monitor); The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
Experimental: 1st: L eye no video. 2nd: R eye video; The left eye will be examined first without video, followed by the right eye with video.	Other: Video (played on a computer monitor); The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of visualizing the optic disk within 60 seconds	To determine whether showing a video clip with sound of the patient's choice can improve the success of fundoscopic exam in children as defined by the ability to visualize the optic disk within 60 seconds.	At the time of fundoscopy exam

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the amount of time needed to visualize the optic disk.	To determine whether showing a video clip with sound of the patient's choice can reduce the amount of time needed to perform a successful fundoscopic exam.	At the time of fundoscopy exam
Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam.	Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam as determined by a 10 point likert scale (1 being easiest and 10 being hardest).	At the time of fundoscopy exam

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Ash Singhal, MD, University of British Columbia

Publications and helpful links

General Publications

• Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.
• Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
• de la Barra F, Toledo V, Rodriguez J. Prediction of behavioral problems in Chilean schoolchildren. Child Psychiatry Hum Dev. 2005 Spring;35(3):227-43. doi: 10.1007/s10578-004-6459-9.
• Colares V, Richman L. Factors associated with uncooperative behavior by Brazilian preschool children in the dental office. ASDC J Dent Child. 2002 Jan-Apr;69(1):87-91, 13.
• Hussein MA, Coats DK, Paysse EA. Use of the RetCam 120 for fundus evaluation in uncooperative children. Am J Ophthalmol. 2004 Feb;137(2):354-5. doi: 10.1016/S0002-9394(03)00867-5.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimated): August 28, 2012

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: pediatric; clinical examination; optic disk; fundoscopy
• Additional Relevant MeSH Terms: Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: H11-01885