<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/NCT02978079</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-Nr. 2016-02151</org_study_id>
    <nct_id>NCT02978079</nct_id>
  </id_info>
  <brief_title>Pupillometry in Horner's Syndrome</brief_title>
  <official_title>Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye&#xD;
      and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the&#xD;
      sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of&#xD;
      the etiologies for ischemic stroke in young patients.&#xD;
&#xD;
      In our current study, we will explore the diagnostic accuracy of automated binocular&#xD;
      pupillometry in the diagnosis or HS, and its potential in identifying dissection of the&#xD;
      carotid artery in patients of young age who suffer ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection</measure>
    <time_frame>1 day of initial visit</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">135</enrollment>
  <condition>Horner's Syndrome</condition>
  <condition>Stroke</condition>
  <condition>Dissection Carotid Artery</condition>
  <arm_group>
    <arm_group_label>Pupillometry in stroke patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All eligible patients will undergo pupillometry test for the finding of Horner's syndrome</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated pupillometry</intervention_name>
    <description>Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome</description>
    <arm_group_label>Pupillometry in stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 60 years of age or younger&#xD;
&#xD;
          -  Acute stroke (less than 72 hours from admission)&#xD;
&#xD;
          -  Informed Consent as documented by signature (Appendix Informed Consent Form)&#xD;
&#xD;
          -  Ability to understand the study information and consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known history of HS&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc.&#xD;
&#xD;
          -  Medications affecting pupillary response&#xD;
&#xD;
          -  History of ocular surgery affecting the pupil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Konrad P Weber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ophthalmology Department, University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ophthalmology Department, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>CH-8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Konrad P Weber, MD</last_name>
      <phone>0041442555549</phone>
      <email>KONRAD.WEBER@USZ.CH</email>
    </contact>
    <investigator>
      <last_name>Konrad P Weber, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Konrad Peter Weber</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Horner Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02978079
org study id: KEK-Nr. 2016-02151
nct id: NCT02978079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Horner's syndrome (HS) is a result of interruption of the sympathetic innervation to the eye
      and ocular adnexa, which can occur due to carotid artery dissection (CAD), along which the
      sympathetic nerve fibers travel to reach the eye. Dissection of the carotid artery is one of
      the etiologies for ischemic stroke in young patients.

      In our current study, we will explore the diagnostic accuracy of automated binocular
      pupillometry in the diagnosis or HS, and its potential in identifying dissection of the
      carotid artery in patients of young age who suffer ischemic stroke.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection
time frame: 1 day of initial visit
arm group label: Pupillometry in stroke patients
arm group type: Experimental
description: All eligible patients will undergo pupillometry test for the finding of Horner's syndrome
intervention type: Device
intervention name: Automated pupillometry
description: Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome
arm group label: Pupillometry in stroke patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Konrad P Weber, MD
role: Principal Investigator
affiliation: Ophthalmology Department, University Hospital Zurich
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Zurich
investigator full name: Konrad Peter Weber
investigator title: Principal Investigator
mesh term: Horner Syndrome
mesh term: Syndrome
sharing ipd: No