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

Stroke Clinical Trial

— STROKAO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712747
• Other study ID #: MMT_2020_28
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: January 25, 2025

Study information

• Verified date: February 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie YAVCHITZ, MD
• Phone: 01 48 03 64 54
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 25, 2025
• Est. primary completion date: January 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Blood pressure measurement at rest
At the inclusion visit

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschuld	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)