Skip to main content
OpenTrials
Completed

NCT Number: NCT04363619

Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, CH-8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT and OCTA

Diagnostic Test

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

Primary outcomes

  1. i. Number of fundus photography, OCT, and OCTA examinations with usable and quantifiable results.

    Time frame: From hospital entry up to 3-6 months

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: RETINA-ICH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 27, 2020
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.