NCT06416371 Retinal Vessel Leakage in Cerebral Small Vessel Disease
| NCT ID | NCT06416371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Cerebral Small Vessel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2029-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-01-13 with a primary completion date of 2029-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are: * Does retinal vessel leakage occur in cerebral small vessel disease? * If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally? Participants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels. Participants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.
Eligibility Criteria
Inclusion Criteria: * Membership in the Mild Stroke Study 3 cohort * Contrast enhanced MRI within 12 months * Clear optical media in both eyes, as assessed by study investigator * Best corrected visual acuity (near vision) ≥N36 Exclusion Criteria: * Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension) * Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF) * Recent eye surgery * Shallow anterior chambers as assessed by torch test * Pregnancy, renal failure * Severe dementia * Known allergy to fluorescein * History of allergy such as food or drug induced urticaria or history of bronchial asthma * Any other severe or acute medical or psychiatric conditions * Inability to give informed consent
Frequently Asked Questions
Who can join the NCT06416371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Small Vessel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06416371 currently recruiting?
Yes, NCT06416371 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Edinburgh to inquire about joining.
Where is the NCT06416371 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT06416371 clinical trial?
NCT06416371 is sponsored by University of Edinburgh. The trial plans to enroll 40 participants.