Pupillometry in Horner's Syndrome

January 8, 2021 updated by: Konrad Peter Weber, University of Zurich

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, CH-8091
        • Recruiting
        • Ophthalmology Department, University Hospital Zurich
        • Contact:
        • Principal Investigator:
          • Konrad P Weber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 day of initial visit
1 day of initial visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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