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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Procedure: Ophthalmological examinations; Procedure: Blood pressure measurement at rest

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Amélie YAVCHITZ, MD; Phone Number: +33 01 48 03 64 54; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschuld
    • Contact: Martine MAUGET FAYSSE, MD; Phone Number: +33 0148036437; Email: mmfaysse@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Inpatients with confirmed stroke for less than 10 days and controls (Individuals presenting at the Rothschild Foundation Hospital with no history of stroke)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases - patients with stroke; Ophthalmological examinations : At the inclusion visit and 3 months after their stroke Blood pressure measurement at rest : At the inclusion visit	Procedure: Ophthalmological examinations; 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.; Procedure: Blood pressure measurement at rest; At the inclusion visit
Controls - Individuals with no history of stroke; Ophthalmological examinations : At the inclusion visit Blood pressure measurement at rest : At the inclusion visit	Procedure: Ophthalmological examinations; 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.; Procedure: Blood pressure measurement at rest; At the inclusion visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wall thickness (WT) in adaptive optics	Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls	At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Wall cross-sectional area (WCSA) in adaptive optics	Measured in µm², Comparison between groups : hemorrhagic strokes, ischemic strokes, controls	At the inclusion visit (less than 10 days after the stroke for the patients with stroke)
Wall to lumen ratio (WLR) in adaptive optics	Comparison between groups : hemorrhagic strokes, ischemic strokes, controls	At the inclusion visit (less than 10 days after the stroke for the patients with stroke)

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Martine MAUGET FAYSSE, MD, Hôpital Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): January 25, 2025
• Study Completion (Estimated): January 25, 2025

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Adaptive optics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MMT_2020_28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No