Insights From the Retina on Cerebral Microvascular Dysfunction in Haemorrhagic Stroke

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04363619

Acronym

RETINA-ICH

Enrollment

Registered

2020-04-27

Start date

2021-02-23

Completion date

2022-07-28

Last updated

2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Brief 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.

Detailed 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

Interventions

DIAGNOSTIC_TESTOCT and OCTA

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026