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Video Diversion During Fundoscopic Exam in Children

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01673815
Acronym
CAFE
Enrollment
60
Registered
2012-08-28
Start date
2011-08-01
Completion date
2012-08-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Disorders of Optic Disc, Bilateral

Keywords

optic disk, fundoscopy, pediatric, clinical examination

Brief summary

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.

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.

Interventions

OTHERVideo (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.

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success rate of visualizing the optic disk within 60 secondsAt the time of fundoscopy examTo 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

MeasureTime frameDescription
Reduction in the amount of time needed to visualize the optic disk.At the time of fundoscopy examTo 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.At the time of fundoscopy examImprovement 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).

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORAsh Singhal, MD

University of British Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026