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

NCT04712747 | Completed

• 1 other identifier: MMT_2020_28
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Adaptive optics

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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; Procedure: Blood pressure measurement at rest

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; Procedure: Blood pressure measurement at rest

Interventions

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.

Cases - patients with stroke; Controls - Individuals with no history of stroke

Blood pressure measurement at rest PROCEDURE

At the inclusion visit

Cases - patients with stroke; Controls - Individuals with no history of stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Martine MAUGET FAYSSE, MD

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 15, 2021
• Study Start: January 25, 2021
• Primary Completion: January 14, 2025
• Study Completion: January 14, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)