Horner's SyndromeNCT02978079
Pupillometry in Horner's Syndrome
A study testing Automated pupillometry in people with Horner's Syndrome and Stroke, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Horner's Syndrome, Stroke, Dissection Carotid Artery
- What is being tested?
- Automated pupillometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Feb 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Ophthalmology Department, University Hospital Zurich
Zurich, CH-8091
Konrad P Weber, MD, 0041442555549, KONRAD.WEBER@USZ.CH
Konrad P Weber, MD
About this study
Official title: 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.
- Conditions
- Horner's Syndrome, Stroke, Dissection Carotid Artery
- Being tested
- Automated pupillometry
- Medical subject headings
- Horner Syndrome, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated pupillometryDevice
Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome
| Study group | Role | What they receive |
|---|---|---|
| Pupillometry in stroke patients | Experimental | All eligible patients will undergo pupillometry test for the finding of Horner's syndrome Receives: Device: Automated pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection
Measured: 1 day of initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study start15 Feb 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horner's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konrad Peter Weber, University of Zurich
- Investigators
- Konrad P Weber, MD, Principal investigator, Ophthalmology Department, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978079
- Sponsor's protocol ID
- KEK-Nr. 2016-02151
- Status last verified
- Jan 2021
- First submitted
- 28 Nov 2016
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Pupillometry for the Diagnosis of Horner's Syndrome in Acute Stroke Patients Due to Carotid Artery Dissection
- ClinicalTrials.gov ID
- NCT02978079
- Acronym / sponsor ID
- KEK-Nr. 2016-02151
- Conditions
- Horner's Syndrome, Stroke, Dissection Carotid Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pupillometry in stroke patients | Experimental | Device: Automated pupillometryAll eligible patients will undergo pupillometry test for the finding of Horner's syndrome |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated pupillometryAutomated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome | Device | Pupillometry in stroke patients |
Primary outcome
Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection
Time frame: 1 day of initial visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ophthalmology Department, University Hospital Zurich
Zurich, Switzerland
Konrad P Weber, MD principal investigator
Ophthalmology Department, University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated pupillometry in people with Horner's Syndrome and Stroke, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finding of pupillary dilation lag using pupillometry in patients with acute stroke due to carotid artery dissection (time frame: 1 day of initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.