Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke. A Prospective Observational Study

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Diagnostic Test: OCT and OCTA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Controls<br> | Diagnostic Test: OCT and OCTA<br>* Fundoscopy, OCT and OCTA will be performed 4 times in patients<br>|
| Experimental: ICH<br> | Diagnostic Test: OCT and OCTA<br>* Fundoscopy, OCT and OCTA will be performed 4 times in patients<br>|
| Experimental: aSAH<br> | Diagnostic Test: OCT and OCTA<br>* Fundoscopy, OCT and OCTA will be performed 4 times in patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results. |  | From hospital entry up to 3-6 months |