Other Disorders of Optic Disc, Bilateral Clinical Trial
— CAFEOfficial title:
Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial
| Verified date | August 2012 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2012 |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 1 Year to 8 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Canada | BC Children's Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
Colares 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. — View Citation
de la Barra F, Toledo V, Rodríguez J. Prediction of behavioral problems in Chilean schoolchildren. Child Psychiatry Hum Dev. 2005 Spring;35(3):227-43. — View Citation
Hussein 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. — View Citation
Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At the time of fundoscopy exam | No |
| Secondary | 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. | At the time of fundoscopy exam | No |
| Secondary | 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). | At the time of fundoscopy exam | No |