- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02784132
Video Diversion Improves Success Rate of Fundoscopic Examination in Children
April 28, 2026 updated by: Ash Singhal, University of British Columbia
Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3V4
- BC Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Study Arm A
Right eye examined first with video diversion then left eye examined without video diversion
|
The intervention is playing a video on a computer or iPad (using www.youtube.com)
while performing fundoscopy.
|
|
Other: Study Arm B
Right eye examined first without video diversion then left eye examined with video diversion
|
The intervention is playing a video on a computer or iPad (using www.youtube.com)
while performing fundoscopy.
|
|
Other: Study Arm C
Left eye examined first with video diversion then right eye examined without video diversion
|
The intervention is playing a video on a computer or iPad (using www.youtube.com)
while performing fundoscopy.
|
|
Other: Study Arm D
Left eye examined first without video diversion then right eye examined with video diversion
|
The intervention is playing a video on a computer or iPad (using www.youtube.com)
while performing fundoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Success rate of visualizing the optic disc within 60 seconds
Time Frame: 60 second
|
60 second
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time required to visualize the optic disc
Time Frame: 60 seconds
|
60 seconds
|
|
Ease of performing fundoscopy
Time Frame: 60 seconds
|
60 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ash Singhal, Dr., The University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 24, 2016
First Submitted That Met QC Criteria
May 24, 2016
First Posted (Estimated)
May 26, 2016
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 28, 2026
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- H12-02053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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