RecruitingOBSERVATIONAL

Prospective Ocular Imaging for Intracranial Pressure Evaluation

Doctors often need to check the pressure around your brain, especially if there's a serious medical problem. Currently, this can involve uncomfortable or even risky procedures like a spinal tap (lumbar puncture) or inserting a small tube into your brain. This study is trying to find a safer and easier way using special cameras to look at the back of your eyes. Most people have a small, natural pulse in a blood vessel near the nerve connecting your eye to your brain. This pulse often disappears when the pressure around the brain is too high. Researchers are collecting lots of pictures and videos of this pulse from people with and without brain pressure issues. They hope to teach a computer program to automatically detect this pulse and, over time, help estimate brain pressure without needing to do invasive tests.

At a glance

Status

Recruiting

Sponsor

King's College Hospital NHS Trust

Enrolment target

160

Start

10 Jan 2025

Estimated completion

30 Nov 2025

Idiopathic Intracranial Hypertension Intracranial Pressure Increase Spontaneous Venous Pulsations

What is this study about?

Imagine the space around your brain and spinal cord is like a gently cushioned bag of fluid. The pressure in this system is usually quite stable. However, if this pressure gets too high, it can lead to serious health problems, including headaches, vision loss, and in severe cases, even brain damage or be life-threatening. Conditions like Idiopathic Intracranial Hypertension (IIH) or after head injuries are just a few examples where knowing this pressure is really important.

Currently, the most accurate ways to measure this pressure involve procedures that go inside your body. This could be a lumbar puncture, where a needle is put into your lower back to draw fluid and measure pressure, or in some cases, a small device (an ICP bolt) might even be placed directly into your brain. While these tests are accurate, they can be uncomfortable, carry risks like pain, infection, or bleeding, and often require you to stay in hospital.

This study is trying to develop a simple, pain-free way to check this brain pressure by just looking into your eyes. Most people have a tiny, natural pulse in a blood vessel at the back of their eye, close to where the optic nerve (the nerve that connects your eye to your brain) begins. When the pressure around the brain goes up, this little pulse often disappears. The researchers are using special cameras to take high-quality pictures and videos of this area in people — some who have normal brain pressure and some who might have higher pressure. The goal is to build a computer program that can automatically spot this pulse (or its absence) and eventually help doctors get an idea of your brain pressure without needing any invasive tests. This could make checking brain pressure much easier and safer for everyone.

Key takeaways

This study aims to find an easier, safer way to check brain pressure.
It uses special eye cameras to look for a tiny pulse at the back of your eye.
This pulse can disappear if brain pressure is too high.
The goal is to teach a computer to spot this pulse and estimate brain pressure.
This could reduce the need for uncomfortable and risky tests like spinal taps.

Who may be eligible?

The study is looking for two main groups of people. The first group includes healthy adults aged 18 or older who are already having a routine eye scan (called an OCT scan) and don't have any known issues with their brain pressure. However, you wouldn't be able to join if you have serious eye conditions that make it hard to get clear pictures of the back of your eye, or if you have certain eye problems like glaucoma or diabetic retinopathy.

Additionally, you can't be in this healthy group if you currently have or have had conditions that affect brain pressure, such as certain brain tumours, epilepsy, serious head injuries, or specific infections. Also, if you're taking medications known to affect brain pressure, like certain steroids or acne treatments, or if you're physically unable to participate in the eye tests, you wouldn't be suitable.

The second group they are looking for are adults aged 18 or older who are already scheduled to have a lumbar puncture (spinal tap) or have a device called an ICP monitor inserted. These are people who doctors already believe might have issues with their brain pressure and need direct measurement tests. The study wants to collect eye images from these individuals at the same time as their invasive tests are planned.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have good vision (even with glasses/lenses) and no major eye conditions like severe glaucoma?
Do you NOT have a history of serious brain pressure problems (e.g., certain tumours, severe head injury, epilepsy)?
Are you NOT taking certain medications that affect brain pressure (e.g., some steroids, certain acne drugs)?
Are you able to sit still for eye exams?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve having your eyes examined with special cameras. These cameras will take high-quality pictures and videos of the back of your eyes, focusing on a tiny blood vessel near your optic nerve. They might use different types of cameras, including hand-held ones and larger machines. For most people, this will likely be part of an existing eye appointment. If you are in the group already having a lumbar puncture or ICP bolt, the eye imaging will be done around the same time as those procedures. You will not receive any new medications as part of this study. The total duration of your participation would involve a single set of imaging sessions, taking perhaps 30-60 minutes.

Potential risks and benefits

A potential benefit of joining this study is helping to develop a new, non-invasive way to check brain pressure that could avoid uncomfortable and risky procedures in the future for many patients. This could significantly improve patient care. There are very few risks involved in the eye imaging part of the study; it’s similar to standard eye tests you might have. You may experience some temporary bright lights from the cameras, and your pupils might be widened with eye drops, which can cause temporary blurry vision and light sensitivity. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

King's Ophthalmology Research Unit
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is the 'pulse' they are looking for?

It's a tiny, natural pulse in a blood vessel at the back of your eye, near the nerve that connects your eye to your brain. It's often there when your brain pressure is normal.

Why is it important to measure pressure around the brain?

High pressure can cause serious health problems like headaches and vision loss, and can sometimes be life-threatening if not found and treated.

Will taking part involve any pain?

No, the eye imaging part of the study is not painful. It's similar to getting your eyes checked at the optician, though you might have bright lights briefly and temporary blurry vision from eye drops.

Do I need to take any new medicines for this study?

No, you won't be given any new medicines as part of this study.

How long will my participation take?

You will only need to attend for a single session of eye imaging, which will likely take about 30 to 60 minutes.

How to find out more

King's Ophthalmology Research Unit

kch-tr.ophthalmologyresearch@nhs.net +44 203 299 7791 Official trial record

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