Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry

Background: Large vessel carotid stenosis represent significant cause of ischaemic stroke. Indication for surgical revascularisation treatment relies on severity stenosis and clinical symptoms. Mild clinical symptoms such as transient ischemic attack, amaurosis fugax or minor stroke preceded large strokes in only 15% of cases.

Aim: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry could be used to better evaluate perfusion in post-stenotic basin. The investigators presume the more stenotic blood vessel, the more reduced retinal perfusion is resulting in adaptive changes such as higher arteriovenous saturation difference due to greater oxygen extraction. This could help broaden the indication spectrum for revascularisation treatment for carotid stenosis.

Methods: The investigators plan to enroll 50 patients a year with significant carotid stenosis and cross-examine them with retinal oximetry. Study group will provide both stenotic vessels and non-stenotic vessels forming the control group. Patients with significant carotid stenosis will undergo an MRI examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters.

Statistics: Correlation between the severity of stenosis and retinal oximetry parameters will be compared to the control group of non-stenotic sides with threshold of 70%, respectively 80% and 90% stenosis. Data will be statistically evaluated at the 5% level of statistical significance. Results will be then reevaluated with emphasis on MRI findings in the carotid basin.

Conclusion: This prospective case control study protocol wil be used to launch a trial assessing the relationship between significant carotid stenosis and retinal perfusion measured via automated retinal oximetry.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Stenosis, Carotid
• Intervention / Treatment: Diagnostic test: Automated retinal oximetry

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Michal Král, MD., Ph.D.; Phone Number: +420604171594; Email: michal.kral@fnol.cz

Study Locations

• Czechia
  • Olomouc, Czechia, 775 20
    • Recruiting
    • University Hospital Olomouc
    • Contact: Michal Kral, MD; Phone Number: +420 604 171 594; Email: michal.kral@fnol.cz
    • Principal Investigator: Michal Kral, MD
    • Sub-Investigator: Daniel Sanak, MD,PhD
    • Sub-Investigator: Petr Polidar, MD
    • Sub-Investigator: Barbora Pašková, MD
    • Sub-Investigator: Marta Karhanová, MD, Ph.D.
    • Sub-Investigator: Tomáš Dorňák, MD, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population will include patients examined in Neurosonological laboratory in Neurology department of University Hospital Olomouc,

Description

Inclusion Criteria:

Study population will include patients examined in ultrasound laboratory in Neurology department of University Hospital Olomouc, regardless of incidental finding of stenosis, examination due to acute symptoms or regular checkup of known stenosis.

Exclusion Criteria:

• patients unable undergo ophthalmological examination properly, especially on automated retinal oximetry.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Internal Carotid Artery Stenosis; Group of patients with internal carotid stenosis detected via ultrasound examination.	Diagnostic test: Automated retinal oximetry; Non invasive standard examination on automated retinal oximetry.
Non stenotic Internal Carotid Artery; Group of patients without internal carotid stenosis on ultrasound examination.	Diagnostic test: Automated retinal oximetry; Non invasive standard examination on automated retinal oximetry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.	To establish whether arterio-venous difference in the stenotic basin increases with the severity of stenosis and/or these changes vary depending on the severity of stenosis.	2028

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with MRI ischaemic lesions	with clinically symptomatic and asymptomatic carotid stenosis correlated to MRI findings of ipsilateral ischaemic lesions in the stenotic basin.	2029

Collaborators and Investigators

• Sponsor: University Hospital Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: automated retinal oximetry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Stroke; Ischemic Stroke; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: NW24-06-00380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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