Evaluating eye blood flow in patients with carotid artery stenosis
Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
This study is testing how blood flow to the eyes changes in patients with a narrowed carotid artery before and after they have surgery, and comparing it to healthy people to learn more about eye health related to this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06398223 on ClinicalTrials.gov |
What this trial studies
This study aims to assess ocular blood flow and optic nerve head blood flow in patients with unilateral carotid artery stenosis before and after undergoing carotid endarterectomy or carotid artery stenting. It will also compare these measurements with those from healthy age- and sex-matched control subjects. Additionally, the study seeks to evaluate brain tissue oxygenation during the procedures and explore potential correlations between ocular and cerebral blood flow using advanced imaging techniques like Laser Speckle Flowgraphy and Near-Infrared Spectroscopy. The goal is to enhance understanding of ocular ischemia related to carotid artery stenosis.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 and older with unilateral carotid artery stenosis scheduled for carotid endarterectomy or stenting.
Not a fit: Patients with significant ocular inflammation or clinically relevant illnesses in the three weeks prior to the study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for preventing ocular and systemic ischemic complications in patients with carotid artery stenosis.
How similar studies have performed: While there have been studies on ocular blood flow, this approach using LSFG and NIRS in the context of carotid artery stenosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for patients with unilateral carotid artery stenosis: * Men and Women aged ≥ 18 years * Signed informed consent * Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant * Diagnosis of unilateral carotid artery stenosis and scheduled carotid endarterectomy or carotid artery stenting Inclusion criteria for healthy age- and sex-matched control subjects: * Men and Women aged ≥ 18 years * Signed informed consent * Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant * Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant * Non-Smokers Exclusion criteria for patients with carotid artery stenosis and healthy age- and sex-matched control subjects: * Blood donation in the three weeks preceding the study * Symptoms of a clinically relevant illness in the three weeks preceding the study * Ocular inflammation or infection within the last 3 months * History of family history of epilepsy * Diabetes mellitus type 1 or type 2 * Pregnant or breast-feeding women * Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
Where this trial is running
Vienna
- Department of Clincal Pharmacology, Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Gerhard Garhöfer, Assoc. Prof. Priv. Doz. MD
- Email: klin-pharmakologie@meduniwien.ac.at
- Phone: +43 1 40400 29880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.