Retinal Vessel Leakage in Cerebral Small Vessel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adults \>18 years old with mild ischaemic stroke with a modified Rankin scale (mRS) greater or equal to 2 at recruitment presenting to Edinburgh/Lothian stroke services. For details see Clancy, et al (2021) Rationale and design of a longitudinal study of cerebral small vessel diseases, clinical and imaging outcomes in patients presenting with mild ischaemic stroke: Mild Stroke Study 3. European Stroke Journal 6:81-88. https://doi.org/10.1177/2396987320929617
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Fundus fluorescein angiography, with ultrawide field retinal imaging
Diagnostic testIntravenous injection of sodium fluorescein for angiography of retinal blood vessels
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Retinal vessel leakage by automated segmentation
The presence and severity of retinal vessel leakage will be measured for each eye in terms of change in pixel brightness over the duration of the angiogram.
Time frame
within one angiogram2
Retinal vessel leakage by manual grading
The presence and severity of retinal vessel leakage will be measured using an manual ordinal grading scale
Time frame
within one angiogramSecondary outcomes
1
Baseline blood-brain barrier breakdown
BBB breakdown is measured by MRI in terms of image enhancement after intravenous gadolinium
Time frame
Within one MRI scan2
White matter hyperintensity (WMH) volume adjusted for brain volume
This is measured from the most recent structural MRI scan
Time frame
Within one MRI scan3
Change in white matter hyperintensity (WMH) volume adjusted for brain volume
This is measured by comparing the most recent structural MRI scan with the baseline structural MRI scan
Time frame
Difference in MRI scans up to 5 years prior4
Fazekas score
This is measured from the most recent structural MRI scan
Time frame
Within one MRI scanSponsors and contacts
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Source ClinicalTrials.gov