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

NCT06085612 | Recruiting DMC

• 1 other identifier: NW24-06-00380
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic; Stenosis, Carotid

Keywords

automated retinal oximetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation with MRI ischaemic lesions

  2029

Study Arms (2)

Internal Carotid Artery Stenosis

Group of patients with internal carotid stenosis detected via ultrasound examination.

Diagnostic Test: Automated retinal oximetry

Non stenotic Internal Carotid Artery

Group of patients without internal carotid stenosis on ultrasound examination.

Diagnostic Test: Automated retinal oximetry

Interventions

Automated retinal oximetry DIAGNOSTIC_TEST

Non invasive standard examination on automated retinal oximetry.

Internal Carotid Artery Stenosis; Non stenotic Internal Carotid Artery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

University Hospital Olomouc

Olomouc, 775 20, Czechia

RECRUITING

Related Publications (1)

• Polidar P, Paskova B, Karhanova M, Sin M, Dornak T, Schreiberova Z, Divisova P, Veverka T, Franc D, Sanak D, Kral M. Study protocol - Prospective case-control trial - Impact of significant carotid stenosis on retinal perfusion measured with automated retinal oximetry. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Mar;169(1):66-71. doi: 10.5507/bp.2023.052. Epub 2024 Jan 3.

  PMID: 38192247 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Arterial Occlusive Diseases

Central Study Contacts

Michal Král, MD., Ph.D.

CONTACT

+420604171594; michal.kral@fnol.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 17, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)