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Pupillometry in Horner's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02978079
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Konrad Peter Weber, University of Zurich

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Horner's Syndrome Stroke Dissection Carotid Artery Device: Automated pupillometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pupillometry in stroke patients
All eligible patients will undergo pupillometry test for the finding of Horner's syndrome
Device: Automated pupillometry
Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome

Primary Outcome Measures :
  1. Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection [ Time Frame: 1 day of initial visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults 60 years of age or younger
  • Acute stroke (less than 72 hours from admission)
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Ability to understand the study information and consent form

Exclusion Criteria:

  • known history of HS
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • Medications affecting pupillary response
  • History of ocular surgery affecting the pupil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02978079

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Ophthalmology Department, University Hospital Zurich Recruiting
Zurich, Switzerland, CH-8091
Contact: Konrad P Weber, MD    0041442555549    KONRAD.WEBER@USZ.CH   
Principal Investigator: Konrad P Weber, MD         
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Konrad P Weber, MD Ophthalmology Department, University Hospital Zurich
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Responsible Party: Konrad Peter Weber, Principal Investigator, University of Zurich Identifier: NCT02978079    
Other Study ID Numbers: KEK-Nr. 2016-02151
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Horner Syndrome
Pathologic Processes
Nervous System Diseases
Autonomic Nervous System Diseases
Pupil Disorders
Neurologic Manifestations
Eye Diseases