BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
Completed
NCT Number: NCT01673815
Video Diversion During Fundoscopic Exam in Children
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
1 year–8 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Video (played on a computer monitor)
OtherThe intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
Primary outcomes
-
Success rate of visualizing the optic disk within 60 seconds
Time frame: At the time of fundoscopy exam
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.
Secondary outcomes
-
Reduction in the amount of time needed to visualize the optic disk.
Time frame: At the time of fundoscopy exam
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.
-
Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam.
Time frame: 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 as determined by a 10 point likert scale (1 being easiest and 10 being hardest).
Sponsors and collaborators
Lead sponsor
University of British Columbia
Other
Registry information
Official study title
Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial
Acronym: CAFE
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Aug 28, 2012
- Registry last updated
- May 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.