RecruitingNCT06855342

Prospective Ocular Imaging for Intracranial Pressure Evaluation


Sponsor

King's College Hospital NHS Trust

Enrollment

160 participants

Start Date

Jan 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is a prospectively recruiting, database development study collecting images and videos of the spontaneous venous pulsation at the back of people's eyes - this is a pulse one can see on examination of the back of the eye, originating from the blood vessels around the nerve that connects the eye to the brain (the optic nerve), and is present in most people who have normal pressure around the brain. However, in people with raised pressure in the brain, this pulse disappears as the pressure rises. Many things can cause the pressure around the brain to increase, including tumours, swellings and trauma. The investigators want to test if high-quality images and videos of this pulse, taken using both hand-held and larger, fixed-platform machines, can be used to train a software tool to automatically detect this pulse. The investigators want to collect these images and videos in 2 groups of patients: those with no known or suspected brain pressure problems, and those who are suspected to have raised pressure and/or are due to undergo measurement of the pressure around the brain, called lumbar punctures or intracranial pressure bolt monitoring. These tests to check the pressure around the brain are invasive - they involve inserting needles in the back or directly into the brain to measure the pressure, and carry risks. The value of these two groups of people will be to help train the software to reasonably say whether a pulse is present or absent and, hopefully, estimate what the pressure around the brain may be without the need for an invasive test.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a special eye scan (using a camera to look at blood vessels in the back of the eye) can non-invasively detect abnormally high pressure inside the skull — a serious condition that normally requires a spinal tap to measure. **You may be eligible if:** - You are 18 years or older - You are a healthy volunteer having a routine eye scan, OR - You are a patient scheduled to have a lumbar puncture (spinal tap) or brain pressure monitoring **You may NOT be eligible if (healthy volunteers):** - You have glaucoma or a family history of glaucoma - You have blocked blood vessels in the eyes - You have diabetic eye disease - You are bedridden or take medications that affect brain pressure (e.g., steroids, certain antibiotics) - You have any history of high brain pressure, brain tumors, seizures, or brain injury **You may NOT be eligible if (patient group):** - You have glaucoma in both eyes - You have blocked blood vessels in both eyes - You are bedridden or unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

King's Ophthalmology Research Unit

London, London, United Kingdom

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NCT06855342


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