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Pupillometry in Horner's Syndrome

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ClinicalTrials.gov Identifier: NCT02978079
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Konrad Peter Weber, University of Zurich

Study Description
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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

Study Design
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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


Arms and Interventions
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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


Outcome Measures
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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 ]

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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02978079


Locations
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Switzerland
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
Investigators
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Principal Investigator: Konrad P Weber, MD Ophthalmology Department, University Hospital Zurich
More Information
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Responsible Party: Konrad Peter Weber, Principal Investigator, University of Zurich
ClinicalTrials.gov 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
Syndrome
Disease
Pathologic Processes
Nervous System Diseases
 Autonomic Nervous System Diseases
Miosis
Pupil Disorders
Neurologic Manifestations
Eye Diseases