Pupillometry in Horner's Syndrome | NCT02978079

Studies
Pupillometry in Horner's Syndrome

NCT02978079

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jan 11, 2021Actual

Enrollment

135Estimated

Phase

Not Applicable

Conditions

Horner's Syndrome
Stroke
Dissection Carotid Artery

Interventions

Automated pupillometry

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2017Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Nov 29, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2021

Last Update Posted Date

Jan 11, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pupillometry in stroke patients	Experimental	All eligible patients will undergo pupillometry test for the finding of Horner's syndrome	Device: Automated pupillometry

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Automated pupillometry	Device	Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome	Pupillometry in stroke patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konrad P Weber, MD	Ophthalmology Department, University Hospital Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology Department, University Hospital Zurich	Recruiting	Zurich		CH-8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006732	Horner Syndrome
D020521	Stroke

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D000096826	Cavernous Sinus Syndromes
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided