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NCT06085612

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

Recruiting now Last updated 23 October 2023
What this trial tests

trial testing Automated retinal oximetry in Stroke, Ischemic in 150 participants. Currently enrolling.

Timeline
1 January 2023
Primary endpoint
1 January 2027
1 January 2028

Quick facts

Lead sponsorUniversity Hospital Olomouc
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment150
Start date1 January 2023
Primary completion1 January 2027
Estimated completion1 January 2028
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Olomouc

Who can join

18 and older, any sex, with Stroke, Ischemic or Stenosis, Carotid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Study protocol - Prospective case-control trial - Impact of significant carotid stenosis on retinal perfusion measured with automated retinal oximetry.
    Polidar P, Paskova B, Karhanova M, Sin M, et al · · 2025 · cited 1× · PMID 38192247 · DOI 10.5507/bp.2023.052
  2. Changes in retinal vessel oxygen saturation using automated retinal oximetry in patients with significant carotid stenosis
    Polidar P, Pašková B, Karhanová M, Sin M, et al · · 2024 · DOI 10.21203/rs.3.rs-4684944/v1

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Other recruiting trials for Stroke, Ischemic

Currently open trials in the same condition.

Other University Hospital Olomouc trials

Trials by the same sponsor.

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Data sources for this page

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