Pupillometry in Horner's Syndrome

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT02978079

Collaborator

(none)

135

Enrollment

Location

Arm

70.5

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Horner's Syndrome Stroke Dissection Carotid Artery	Device: Automated pupillometry	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 15, 2017

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection [1 day of initial visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Department, University Hospital Zurich	Zurich		Switzerland	CH-8091

Sponsors and Collaborators

University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Konrad Peter Weber, Principal Investigator, University of Zurich

ClinicalTrials.gov Identifier:

NCT02978079

Other Study ID Numbers:

KEK-Nr. 2016-02151

First Posted:

Nov 30, 2016

Last Update Posted:

Jan 11, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Horner Syndrome

Syndrome

Study Results

No Results Posted as of Jan 11, 2021