Impact of Significant Carotid Stenosis on Retinal Perfusion Measured Via Automated Retinal Oximetry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Automated retinal oximetry.
- Who it may be relevant to
- Registry conditions: Stroke, Ischemic, Stenosis, Carotid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test Automated retinal oximetry
Non invasive standard examination on automated retinal oximetry.
Primary outcome measures
- Arterio-venous oxygen difference in retinal blood vessels measured by automated retinal oximetry. [Time frame: 2028]
Secondary outcome measures (1)
- Correlation with MRI ischaemic lesions [Time frame: 2029]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Czechia · 1 center
- University Hospital Olomouc — Olomouc
Publications
- 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
Identifiers
NCT: NCT06085612 · NW24-06-00380