Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke (RETINA-ICH)

University of Zurich (UZH)

Status: Completed

Conditions: Intracerebral Hemorrhage

Treatments: Diagnostic Test: OCT and OCTA

Study type: Interventional

Funder types: Other

Identifiers

NCT04363619

2020-01524

Details and patient eligibility

About

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.

Full 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

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14 participants in 3 patient groups, including a placebo group

Controls

Placebo Comparator group

Treatment:

Diagnostic Test: OCT and OCTA

ICH

Experimental group

Treatment:

Diagnostic Test: OCT and OCTA

aSAH

Experimental group

Treatment:

Diagnostic Test: OCT and OCTA