<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673815</url>
  </required_header>
  <id_info>
    <org_study_id>H11-01885</org_study_id>
    <nct_id>NCT01673815</nct_id>
  </id_info>
  <brief_title>Video Diversion During Fundoscopic Exam in Children</brief_title>
  <acronym>CAFE</acronym>
  <official_title>Video Diversion During Fundoscopic Exam in Children: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fundoscopy is an important aspect of the neurological examination, but can be challenging in&#xD;
      uncooperative children. This study explored whether viewing a video (selected by patient or&#xD;
      caregiver) during eye examination improves the success, duration and ease of pediatric&#xD;
      fundoscopy.&#xD;
&#xD;
      Hypothesis: Showing a short video clip during a fundoscopic exam will increase the&#xD;
      probability of successfully visualizing the optic disk and reduce the amount of time needed&#xD;
      to perform a fundoscopic exam in children between 1-8 years old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine whether showing a video clip with sound of the&#xD;
      patient's choice can improve the ease of fundoscopic exam as defined by improved success of&#xD;
      visualizing the optic disk and the reduction in time needed to perform the exam. The&#xD;
      investigators will also examine the physician's and caregiver's perception on whether the&#xD;
      video was effective in improving the ease of the exam. The purpose of the video is to capture&#xD;
      the visual attention of the patient thereby allowing the physician to swiftly perform the&#xD;
      fundoscopic exam. The literature has suggested that young patients are most uncooperative,&#xD;
      therefore the investigators will focus our study on younger patients 1-8 years old.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of visualizing the optic disk within 60 seconds</measure>
    <time_frame>At the time of fundoscopy exam</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in the amount of time needed to visualize the optic disk.</measure>
    <time_frame>At the time of fundoscopy exam</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in the physician's and caregiver's (parent/legal guardian) perception of the ease of the fundoscopic exam.</measure>
    <time_frame>At the time of fundoscopy exam</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Other Disorders of Optic Disc, Bilateral</condition>
  <arm_group>
    <arm_group_label>1st: R eye video. 2nd: L eye no video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The right eye will be examined first with video, followed by the left eye without video.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1st: R eye no video. 2nd: L eye video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The right eye will be examined without video, followed by the left eye with video.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1st: L eye video. 2nd: R eye no video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The left eye will be examined first with video, followed by the right eye without video.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1st: L eye no video. 2nd: R eye video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The left eye will be examined first without video, followed by the right eye with video.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video (played on a computer monitor)</intervention_name>
    <description>The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.</description>
    <arm_group_label>1st: L eye no video. 2nd: R eye video</arm_group_label>
    <arm_group_label>1st: L eye video. 2nd: R eye no video</arm_group_label>
    <arm_group_label>1st: R eye no video. 2nd: L eye video</arm_group_label>
    <arm_group_label>1st: R eye video. 2nd: L eye no video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1-8 years old&#xD;
&#xD;
          -  Capable of visualizing the video monitor&#xD;
&#xD;
          -  Patient has 2 examinable eyes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blind patient&#xD;
&#xD;
          -  Patients &lt; 1 or &gt; 8 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ash Singhal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BC Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.</citation>
    <PMID>17940248</PMID>
  </reference>
  <reference>
    <citation>Cok OY. Anaesthesia for eye examination. Current Anaesthesia &amp; Critical Care 2008 February 2009;20(1):46.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15731888</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12119822</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/S0002-9394(03)00867-5.</citation>
    <PMID>14962432</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 23, 2012</last_update_submitted>
  <last_update_submitted_qc>August 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>optic disk</keyword>
  <keyword>fundoscopy</keyword>
  <keyword>pediatric</keyword>
  <keyword>clinical examination</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673815
org study id: H11-01885
nct id: NCT01673815
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Success rate of visualizing the optic disk within 60 seconds
time frame: At the time of fundoscopy exam
description: 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.
measure: Reduction in the amount of time needed to visualize the optic disk.
time frame: At the time of fundoscopy exam
description: 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.
measure: 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
description: 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).
arm group label: 1st: R eye video. 2nd: L eye no video
arm group type: Experimental
description: The right eye will be examined first with video, followed by the left eye without video.
arm group label: 1st: R eye no video. 2nd: L eye video
arm group type: Experimental
description: The right eye will be examined without video, followed by the left eye with video.
arm group label: 1st: L eye video. 2nd: R eye no video
arm group type: Experimental
description: The left eye will be examined first with video, followed by the right eye without video.
arm group label: 1st: L eye no video. 2nd: R eye video
arm group type: Experimental
description: The left eye will be examined first without video, followed by the right eye with video.
intervention type: Other
intervention name: Video (played on a computer monitor)
description: The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
arm group label: 1st: L eye no video. 2nd: R eye video
arm group label: 1st: L eye video. 2nd: R eye no video
arm group label: 1st: R eye no video. 2nd: L eye video
arm group label: 1st: R eye video. 2nd: L eye no video
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ash Singhal, MD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
citation: Jan MM. Neurological examination of difficult and poorly cooperative children. J Child Neurol. 2007 Oct;22(10):1209-13. doi: 10.1177/0883073807306262.
PMID: 17940248
citation: Cok OY. Anaesthesia for eye examination. Current Anaesthesia & Critical Care 2008 February 2009;20(1):46.
citation: 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.
PMID: 15731888
citation: 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.
PMID: 12119822
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. doi: 10.1016/S0002-9394(03)00867-5.
PMID: 14962432
responsible party type: Sponsor