FundoscopyNCT02784132
Video Diversion Improves Success Rate of Fundoscopic Examination in Children
A study testing Video diversion in people with Fundoscopy, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Fundoscopy
- What is being tested?
- Video diversion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes
Who cannot join
- Patients who were blind, younger than 1 year of age, or older than 4 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fundoscopy
- Being tested
- Video diversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video diversionOther
The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm A | Other | Right eye examined first with video diversion then left eye examined without video diversion Receives: Other: Video diversion |
| Study Arm B | Other | Right eye examined first without video diversion then left eye examined with video diversion Receives: Other: Video diversion |
| Study Arm C | Other | Left eye examined first with video diversion then right eye examined without video diversion Receives: Other: Video diversion |
| Study Arm D | Other | Left eye examined first without video diversion then right eye examined with video diversion Receives: Other: Video diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of visualizing the optic disc within 60 seconds
Measured: 60 second
Secondary outcomes (2)
Time required to visualize the optic disc
Measured: 60 seconds
Ease of performing fundoscopy
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FundoscopyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ash Singhal, University of British Columbia
- Investigators
- Ash Singhal, Dr., Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784132
- Sponsor's protocol ID
- H12-02053
- Status last verified
- May 2016
- First submitted
- 24 May 2016
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yang MMH, Singhal A, Hengel AR, Kerr JM, St-Pierre GH, George S, Muir K, Thiessen P, Enarson P. Video Diversion Improves Success Rate of Fundoscopic Examination in Children: A Prospective Randomized Controlled Trial. Pediatr Neurol. 2018 Jun;83:32-37. doi: 10.1016/j.pediatrneurol.2017.09.008. Epub 2017 Sep 14.
PubMed 29681489
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Diversion Improves the Success Rate of Fundoscopic Examination in Children: a Prospective Multi-clinic, Multi-practitioner, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02784132
- Acronym / sponsor ID
- H12-02053
- Conditions
- Fundoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Arm A | Other | Other: Video diversionRight eye examined first with video diversion then left eye examined without video diversion |
| Study Arm B | Other | Other: Video diversionRight eye examined first without video diversion then left eye examined with video diversion |
| Study Arm C | Other | Other: Video diversionLeft eye examined first with video diversion then right eye examined without video diversion |
| Study Arm D | Other | Other: Video diversionLeft eye examined first without video diversion then right eye examined with video diversion |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patient aged 1 to 4 years of age (inclusive) with 2 examinable eyes
Key exclusion criteria (1 listed)
- Patients who were blind, younger than 1 year of age, or older than 4 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video diversionThe intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy. | Other | Study Arm A, Study Arm B, Study Arm C, Study Arm D |
Primary outcome
Success rate of visualizing the optic disc within 60 seconds
Time frame: 60 second
2 secondary outcomes
Time required to visualize the optic disc
Time frame: 60 seconds
Ease of performing fundoscopy
Time frame: 60 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 29681489Yang MMH, Singhal A, Hengel AR, Kerr JM, St-Pierre GH, George S, Muir K, Thiessen P, Enarson P. Video Diversion Improves Success Rate of Fundoscopic Examination in Children: A Prospective Randomized Controlled Trial. Pediatr Neurol. 2018 Jun;83:32-37. doi: 10.1016/j.pediatrneurol.2017.09.008. Epub 2017 Sep 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ash Singhal, Dr. principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video diversion in people with Fundoscopy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of visualizing the optic disc within 60 seconds (time frame: 60 second). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784132, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.