NCT02978079

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

4.9 years

First QC Date

November 28, 2016

Last Update Submit

January 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 day of initial visit

Study Arms (1)

Pupillometry in stroke patients

EXPERIMENTAL

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

Device: Automated pupillometry

Interventions

Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome

Pupillometry in stroke patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Department, University Hospital Zurich

Zurich, CH-8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Horner SyndromeStroke

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesCavernous Sinus SyndromesBrain DiseasesCentral Nervous System DiseasesMiosisPupil DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Konrad P Weber, MD

    Ophthalmology Department, University Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2016

First Posted

November 30, 2016

Study Start

February 15, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations