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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04363619
Other study ID # 2020-01524
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2021
Est. completion date July 28, 2022

Study information

Verified date August 2022
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Fundoscopy, optical coherence tomography (OCT) and OCT-angiography (OCTA) are established examinations and bear minimal risks. The recognition of retinal microvascular signs will enhance the pathophysiological understanding of the vasculopathy in patients with intracerebral haemorrhage (ICH) and aneurysmatic subarachnoid hemorrhage (aSAH) and might serve as prognostic and diagnostic indicators.


Description:

The purpose of the study is to - To evaluate the feasibility of fundoscopy, OCT and OCTA imaging in the environment of a Neurocritical Care Unit (NCCU) - To detect, quantify and associate microvascular changes in the retina with signs of micro-vessel disease in ICH and DCI in aSAH


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date July 28, 2022
Est. primary completion date July 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All groups - Primary ICH or aSAH with symptoms onset < 3 days - 18 to unlimited years of age - Signed informed consent obtained from legal representative or patient ICH group - Primary ICH localized either in basal ganglia, thalamus, pons or cerebellum aSAH group - Ruptured aneurysm visualized in contrast-enhanced computed tomography (angio-CT), MRI or cerebral angiography Control group - Stroke due to perimesencepahlic subarachnoid hemorrhage, arteriovenous malformation or isolated traumatic brain injury Exclusion Criteria: - All groups - Cerebral amyloid angiopathy or other neurodegenerative disease - History of migraine with aura or ischemic stroke - Contraindication for pupil dilation (intracranial hypertension, allergy against mydriatics, angle closure glaucoma) - Any pre-existing or manifest ocular condition affecting either the integrity of retinal vessels, transparency of optical media or the risk of acute angle closure glaucoma - Concomitant instable critical illness (e.g. sepsis, multi-organ failure) - Intracranial pressure > 20mmHg and refractory to cerebrospinal fluid drainage - Pregnancy

Study Design


Intervention

Diagnostic Test:
OCT and OCTA
Fundoscopy, OCT and OCTA will be performed 4 times in patients

Locations

Country Name City State
Switzerland University Hospital Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results. From hospital entry up to 3-6 months
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