Pupillometry in Horner's Syndrome

Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Horner's Syndrome; Dissection Carotid Artery
• Intervention / Treatment: Device: Automated pupillometry

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, CH-8091
    • Recruiting
    • Ophthalmology Department, University Hospital Zurich
    • Contact: Konrad P Weber, MD; Phone Number: 0041442555549; Email: KONRAD.WEBER@USZ.CH
    • Principal Investigator: Konrad P Weber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection	1 day of initial visit

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Konrad P Weber, MD, Ophthalmology Department, University Hospital Zurich

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 28, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease; Autonomic Nervous System Diseases; Miosis; Pupil Disorders; Syndrome; Horner Syndrome
• Other Study ID Numbers: KEK-Nr. 2016-02151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No