<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/NCT02228070</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2014-0481</org_study_id>
    <nct_id>NCT02228070</nct_id>
  </id_info>
  <brief_title>Strabismus Measurements Using Automated 3D Video Oculography</brief_title>
  <official_title>Strabismus Measurements Using Automated 3D Video Oculography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Albert Bruppacher-Stiftung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stiftung OPOS zugunsten von Wahrnehmungsbehinderten</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zurich</source>
  <brief_summary>
    <textblock>
      Measuring ocular motility and alignment is important for diagnosing different causes of&#xD;
      strabismus, following patients recovering from cranial nerve palsies, preparing patients for&#xD;
      strabismus surgery and follow-up post surgery. The current clinical gold standards for&#xD;
      measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are&#xD;
      accurate, but require patient cooperation, and are not objective because the patient has to&#xD;
      indicate the position of the light he sees on the screen. Our objective is to develop an&#xD;
      accurate and easy to use goggles system to measure ocular alignment and motility using 3D&#xD;
      video oculography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Validation of video goggles against Hess/Harms screen</measure>
    <time_frame>initial visit</time_frame>
    <description>Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of video goggles in comparison to scleral search coils</measure>
    <time_frame>initial visit</time_frame>
    <description>Measurement of squint angle with 3D video goggles vs. scleral search coils.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen</measure>
    <time_frame>initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months</time_frame>
    <description>Change in squint angle with 3D video goggles and Hess/Harms screen.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Strabismus</condition>
  <arm_group>
    <arm_group_label>strabismus video goggles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>strabismus video goggles</intervention_name>
    <arm_group_label>strabismus video goggles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 11 years or older&#xD;
&#xD;
          -  congenital strabismus&#xD;
&#xD;
          -  acquired strabismus&#xD;
&#xD;
          -  paretic strabismus (oculomotor, abducens and trochlear nerves)&#xD;
&#xD;
          -  before and after strabismus surgery&#xD;
&#xD;
          -  normal controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to sign informed consent&#xD;
&#xD;
          -  Patients with significantly impaired vision&#xD;
&#xD;
          -  Patients unable to cooperate with standard strabismus workup (including Hess and Harms&#xD;
             tests)&#xD;
&#xD;
          -  For sub-study: intolerance to scleral search coils&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ophthalmology Department, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>CH-8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>strabismus</keyword>
  <keyword>oculomotor palsy</keyword>
  <keyword>abducens palsy</keyword>
  <keyword>trochlear palsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Strabismus</mesh_term>
  </condition_browse>
  <!-- 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/NCT02228070
org study id: KEK-ZH-Nr. 2014-0481
nct id: NCT02228070
lead sponsor: 
collaborator: 
collaborator: 
Measuring ocular motility and alignment is important for diagnosing different causes of
      strabismus, following patients recovering from cranial nerve palsies, preparing patients for
      strabismus surgery and follow-up post surgery. The current clinical gold standards for
      measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are
      accurate, but require patient cooperation, and are not objective because the patient has to
      indicate the position of the light he sees on the screen. Our objective is to develop an
      accurate and easy to use goggles system to measure ocular alignment and motility using 3D
      video oculography.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Validation of video goggles against Hess/Harms screen
time frame: initial visit
description: Measurement of squint angle with 3D video goggles vs. Hess/Harms screen.
measure: Accuracy of video goggles in comparison to scleral search coils
time frame: initial visit
description: Measurement of squint angle with 3D video goggles vs. scleral search coils.
measure: Follow-up squint angle measures post-OP and after recovery from cranial nerve palsy with 3D video goggles and Hess/Harms screen
time frame: initial visit, 3 months after surgery, recovery from cranial nerve palsy after 3 months
description: Change in squint angle with 3D video goggles and Hess/Harms screen.
arm group label: strabismus video goggles
arm group type: Experimental
intervention type: Device
intervention name: strabismus video goggles
arm group label: strabismus video goggles
criteria: 
gender: All
minimum age: 11 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Strabismus