Other Disorders of Optic Disc, BilateralCAFENCT01673815
Video Diversion During Fundoscopic Exam in Children
A study testing Video (played on a computer monitor) in people with Other Disorders of Optic Disc, Bilateral, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Disorders of Optic Disc, Bilateral
- What is being tested?
- Video (played on a computer monitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Aug 2012
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1-8 years old
- Capable of visualizing the video monitor
- Patient has 2 examinable eyes
Who cannot join
- Blind patient
- Patients < 1 or > 8 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Other Disorders of Optic Disc, Bilateral
- Being tested
- Video (played on a computer monitor)
- Keywords
- optic disk, fundoscopy, pediatric, clinical examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video (played on a computer monitor)Other
The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
| Study group | Role | What they receive |
|---|---|---|
| 1st: R eye video. 2nd: L eye no video | Experimental | The right eye will be examined first with video, followed by the left eye without video. Receives: Other: Video (played on a computer monitor) |
| 1st: R eye no video. 2nd: L eye video | Experimental | The right eye will be examined without video, followed by the left eye with video. Receives: Other: Video (played on a computer monitor) |
| 1st: L eye video. 2nd: R eye no video | Experimental | The left eye will be examined first with video, followed by the right eye without video. Receives: Other: Video (played on a computer monitor) |
| 1st: L eye no video. 2nd: R eye video | Experimental | The left eye will be examined first without video, followed by the right eye with video. Receives: Other: Video (played on a computer monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of fundoscopy exam
Secondary outcomes (2)
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.
Measured: 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).
Measured: At the time of fundoscopy exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Other Disorders of Optic Disc, BilateralStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673815
- Sponsor's protocol ID
- H11-01885
- Acronym
- CAFE
- Status last verified
- Aug 2012
- First submitted
- 20 Aug 2012
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.
PubMed 17940248Cok 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.
PubMed 15731888Colares 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.
PubMed 12119822Hussein 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.
PubMed 14962432
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 During Fundoscopic Exam in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01673815
- Acronym / sponsor ID
- CAFE / H11-01885
- Conditions
- Other Disorders of Optic Disc, Bilateral
- Keywords
- optic disk, fundoscopy, pediatric, clinical examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 28 Aug 2012 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1st: R eye video. 2nd: L eye no video | Experimental | Other: Video (played on a computer monitor)The right eye will be examined first with video, followed by the left eye without video. |
| 1st: R eye no video. 2nd: L eye video | Experimental | Other: Video (played on a computer monitor)The right eye will be examined without video, followed by the left eye with video. |
| 1st: L eye video. 2nd: R eye no video | Experimental | Other: Video (played on a computer monitor)The left eye will be examined first with video, followed by the right eye without video. |
| 1st: L eye no video. 2nd: R eye video | Experimental | Other: Video (played on a computer monitor)The left eye will be examined first without video, followed by the right eye with video. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1-8 years old
- Capable of visualizing the video monitor
- Patient has 2 examinable eyes
Key exclusion criteria (2 listed)
- Blind patient
- Patients < 1 or > 8 years old
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 (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. | Other | 1st: L eye no video. 2nd: R eye video, 1st: L eye video. 2nd: R eye no video, 1st: R eye no video. 2nd: L eye video, 1st: R eye video. 2nd: L eye no video |
Primary outcome
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.
2 secondary outcomes
Reduction in the amount of time needed to visualize the optic disk.
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.
Time frame: At the time of fundoscopy exam
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.
- Background: PubMed 17940248Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.
- BackgroundCok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
- Background: PubMed 15731888de 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.
- Background: PubMed 12119822Colares 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.
- Background: PubMed 14962432Hussein 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.
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, MD principal investigator
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 (played on a computer monitor) in people with Other Disorders of Optic Disc, Bilateral, 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 3 inclusion and 2 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 disk within 60 seconds (time frame: At the time of fundoscopy exam). 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 NCT01673815, which also lists 5 linked publications.
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.