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NCT Number: NCT06085612

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location status: Recruiting

Location contact

Barbora Pašková, MD

SUB_INVESTIGATOR

Daniel Sanak, MD,PhD

SUB_INVESTIGATOR

Marta Karhanová, MD, Ph.D.

SUB_INVESTIGATOR

Michal Kral, MD

CONTACT

[email protected]

+420 604 171 594

Michal Kral, MD

PRINCIPAL_INVESTIGATOR

Petr Polidar, MD

SUB_INVESTIGATOR

Tomáš Dorňák, MD, Ph.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automated retinal oximetry

Diagnostic Test

Non invasive standard examination on automated retinal oximetry.

Primary outcomes

  1. Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry.

    Time frame: 2028

    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.

Secondary outcomes

  1. Correlation with MRI ischaemic lesions

    Time frame: 2029

    with clinically symptomatic and asymptomatic carotid stenosis correlated to MRI findings of ipsilateral ischaemic lesions in the stenotic basin.

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Král, MD., Ph.D.

CONTACT

[email protected]

+420604171594

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 17, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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