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Pupillometry in Horner's Syndrome

Primary Purpose

Horner's Syndrome, Stroke, Dissection Carotid Artery

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Automated pupillometry
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Horner's Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmology Department, University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pupillometry in stroke patients

Arm Description

All eligible patients will undergo pupillometry test for the finding of Horner's syndrome

Outcomes

Primary Outcome Measures

Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection

Secondary Outcome Measures

Full Information

First Posted
November 28, 2016
Last Updated
January 8, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02978079
Brief Title
Pupillometry in Horner's Syndrome
Official Title
Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horner's Syndrome, Stroke, Dissection Carotid Artery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pupillometry in stroke patients
Arm Type
Experimental
Arm Description
All eligible patients will undergo pupillometry test for the finding of Horner's syndrome
Intervention Type
Device
Intervention Name(s)
Automated pupillometry
Intervention Description
Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome
Primary Outcome Measure Information:
Title
Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection
Time Frame
1 day of initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad P Weber, MD
Organizational Affiliation
Ophthalmology Department, University Hospital Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Department, University Hospital Zurich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konrad P Weber, MD
Phone
0041442555549
Email
KONRAD.WEBER@USZ.CH
First Name & Middle Initial & Last Name & Degree
Konrad P Weber, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pupillometry in Horner's Syndrome

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