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RecruitingOBSERVATIONAL

Retinal Vessel Leakage in Cerebral Small Vessel Disease

This study wants to understand leaky blood vessels in the retina (the back of your eye) in people with a brain condition called cerebral small vessel disease. This condition can lead to strokes and memory problems. We believe that if blood vessels in the eye are leaky, it might be a sign that blood vessels in the brain are also affected. This study will use a special eye scan called fluorescein angiography, which involves injecting a safe dye, to see if these leaks occur. We also want to find out if the amount of leakage in the eye reflects how severe the brain condition is. This could help us understand the disease better and potentially find easier ways to check on new treatments in the future.

At a glance

Status
Recruiting
Sponsor
University of Edinburgh
Enrolment target
40
Start
13 Jan 2025
Estimated completion
15 Feb 2029

What is this study about?

This study is all about understanding a brain condition called cerebral small vessel disease (SVD). This condition affects the tiny blood vessels in your brain and can lead to serious problems like strokes and issues with memory and thinking (vascular dementia).

Scientists don't fully understand what causes SVD, which makes it hard to develop new treatments. One important thing that happens in SVD is that the protective barrier around the brain's blood vessels, called the blood-brain barrier, can become leaky. This leakage can damage brain tissue. Currently, checking for these leaks in the brain often requires expensive and time-consuming brain scans.

However, there's a similar protective barrier in your eyes, called the blood-retina barrier, which is very much like the one in your brain. We believe that if SVD affects the blood vessels in your brain, it might also affect the blood vessels in your eyes in a similar way. So, this study will look for leaks in the tiny blood vessels at the back of your eye using a special imaging technique. If we find that leaky eye vessels are linked to SVD, it could be a simpler, less costly way to understand the disease and track how new treatments are working, without always needing complex brain scans. Participants in this study will be people who are already part of another study called the Mild Stroke Study 3.

Key takeaways

  • We are studying leaks in eye blood vessels to learn about a brain condition.
  • This study uses a special eye scan after an injection of a safe dye.
  • The information gained could help develop easier ways to understand and monitor the disease.
  • Participation requires you to be part of the "Mild Stroke Study 3" cohort.
  • The study involves a single visit for the eye assessment.
  • Your medical care will not be affected if you choose not to take part.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over. You must already be involved in a study called the "Mild Stroke Study 3" and have had a specific type of brain scan (an MRI with contrast dye) within the last year. It's also important that your eyes are generally clear enough for the special camera to take pictures, and that you can see well enough up close.

There are certain reasons why you might not be able to join. These include having other eye conditions that cause leaks, like advanced diabetic retinopathy or some types of macular degeneration. If you've recently had eye surgery or treatment for eye leaks, you wouldn't be able to participate. Also, if you're pregnant, have severe kidney problems, advanced memory loss, or a known allergy to the dye used in the eye scan, this study wouldn't be suitable for you. If you have severe current health problems or can't give your agreement to take part, you also wouldn't be eligible.

Quick self-check
  • Are you aged 18 or older?
  • Are you already a participant in the Mild Stroke Study 3?
  • Have you had a special MRI brain scan within the last year?
  • Do you have generally good vision and clear eyes (no severe cataracts or other blockages)?
  • Are you free from certain other eye conditions that cause leaks or recent eye surgery?
  • Are you not pregnant and do not have severe kidney problems or severe memory loss?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will have a special eye scan called fluorescein angiography. This involves a doctor giving you an injection of a fluorescent dye into a vein in your arm. This dye helps to show up any leaks in the blood vessels at the back of your eye when special cameras take pictures. You will have already had other brain scans and tests as part of your involvement in the Mild Stroke Study 3, and the eye images from this study will add to that information. The total duration of your involvement will likely be a single visit for the eye scan, as your other information will be taken from your previous tests.

Potential risks and benefits

Taking part in research studies is voluntary, and you are free to change your mind or withdraw at any time without affecting your medical care. The potential benefit of this study is that it could help us understand cerebral small vessel disease better, potentially leading to new ways to monitor and treat it in the future. The main risk involved is from the fluorescein angiography, which can cause temporary side effects from the dye, such as nausea or a temporary yellowing of your skin and urine. Allergic reactions to the dye are rare but possible. Researchers will carefully check if this scan is safe for you.

Locations (1)

  • NHS Lothian
    Edinburgh, United Kingdom· Recruiting

Common questions

What is cerebral small vessel disease?

It's a condition that affects the tiny blood vessels in your brain, which can lead to strokes and problems with memory and thinking.

What is fluorescein angiography?

It's a special eye test where a dye is injected into your arm, and then cameras take pictures of your retina to see if blood vessels are leaking.

Will this study cure my condition?

No, this is an observational study, meaning we are learning about the condition, not testing a new treatment or cure.

Is the eye test painful?

The injection of the dye will feel like a typical blood test or injection, but the eye scan itself is usually not painful.

How long will my involvement in the study last?

Your involvement will likely be for a single visit to have the eye scan.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Retinal Vessel Leakage in Cerebral Small Vessel Disease…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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