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

NCT ID: NCT04712747

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2025-01-14

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Ophthalmological examinations

Intervention Type: 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

Intervention Type: PROCEDURE

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

Ophthalmological examinations

Intervention Type: 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

Intervention Type: PROCEDURE

At the inclusion visit

Interventions

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.

Intervention Type: PROCEDURE

Blood pressure measurement at rest

At the inclusion visit

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martine MAUGET FAYSSE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation A. de Rothschild

Locations

Hôpital Fondation A. de Rothschuld

Paris, , France

Countries

France

Other Identifiers

MMT_2020_28

Identifier Type: -

Identifier Source: org_study_id