Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)

The eye has long been recognized as a window to pathological processes occurring in the brain. By imaging the vascular system of the retina scientific understanding and clinical practice have been improved for a wide range of pathologies from diabetes to stroke and dementia.

Adaptive optics (AO) reveals retinal details that remain invisible with other current imaging techniques. Indeed, vessels can be perfectly visualized, making it possible to detect wall irregularities, accurately measure their different structures and monitor their evolution under treatment if necessary.

In AO, studies on retinal vessels involve the calculation of wall thickness (WT), outer diameter (OD), inner diameter (ID), wall cross-sectional area (WCSA) and wall to lumen ratio (WLR). An increase in WLR > 0.31 is characteristic of hypertensive microangiopathy and predictive of cardiovascular and brain damage. This accurate assessment of microvascular structure may even be required in the near future in all patients with arterial hypertension. For vessels > 300 microns in diameter, the increase in vessel wall thickness occurs without changing the ID, a process known as external hypertrophic remodeling. For small arteries < 300 microns, remodeling occurs differently. The total volume of the vessel wall remains constant, but the OD and ID each decrease, a process known as inward eutrophic remodeling.

The objective of this study is to describe the parameters measured in AO in patients in the acute phase of a stroke and then at 3 months.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For the patients with stroke: Inpatients with confirmed stroke (clinical and imaging) for less than 10 days
For the controls: Individuals presenting at the Rothschild Foundation Hospital with no history of stroke who are matched to cases already included in the matching criteria: Age ± 5 years, Gender, high blood pressure (no history, untreated, treated) Diabetes (Yes, No), Body Mass Index (BMI < 25, 25 ≥ BMI < 30, BMI ≥ 30)

Exclusion criteria

Pregnant or breastfeeding woman
Insufficient state of consciousness or physical condition to perform the adaptive optics examination
For the patients with stroke: Hemorrhagic post-traumatic hematoma stroke type, or symptomatic stroke of a brain tumour or an arteriovenous malformation.

Treatment and study plan

Ophthalmological examinations

Procedure

OCT (Optical Coherence Tomography): posterior pole OCT B scan , optic nerve and posterior pole OCT Angiography
Adaptive optics (AO) : Image acquisition on the vessels at the exit of the optic nerve before the first upper temporal bifurcation OD or OG and evaluation of the photoreceptor mosaic. Adaptive optics may require dilatation of the pupil with a drop of tropicamide in the eye examined a few minutes before the examination.
Color retinophotography
Measurement of intraocular pressure

Patients with stroke : At the inclusion visit and 3 months after their stroke Control group : At the inclusion visit.

Blood pressure measurement at rest

Procedure

At the inclusion visit

Primary outcomes

Wall thickness (WT) in adaptive optics

Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Wall cross-sectional area (WCSA) in adaptive optics

Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls
Wall to lumen ratio (WLR) in adaptive optics

Time frame: At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Comparison between groups : hemorrhagic strokes, ischemic strokes, controls

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: STROKAO

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jan 15, 2021
Registry last updated: Dec 10, 2025

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.

Completed