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

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT04712747
Collaborator
(none)
100
1
24.2
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ophthalmological examinations
  • Procedure: Blood pressure measurement at rest

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Adaptive Optics (AO) Analysis of Retinal Arteries in Patients With Recent Stroke (STROKAO)
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Wall thickness (WT) in adaptive optics [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

  2. Wall cross-sectional area (WCSA) in adaptive optics [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

  3. Wall to lumen ratio (WLR) in adaptive optics [At the inclusion visit (less than 10 days after the stroke for the patients with stroke)]

    Comparison between groups : hemorrhagic strokes, ischemic strokes, controls

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Fondation A. de Rothschuld Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, MD, Hôpital Fondation A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT04712747
Other Study ID Numbers:
  • MMT_2020_28
First Posted:
Jan 15, 2021
Last Update Posted:
Feb 7, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 7, 2022