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
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