Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06855342

Prospective Ocular Imaging for Intracranial Pressure Evaluation

Led by King's College Hospital NHS Trust · Updated on 2025-08-03

160

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

Sponsors

K

King's College Hospital NHS Trust

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prospective Ocular Imaging for Intracranial Pressure Evaluation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Presumed normal intracranial pressure undergoing routine mydriatic ophthalmology OCT scans (for healthy controls)
  • Patients scheduled to undergo lumbar puncture with measurement of cerebrospinal fluid pressures
  • Patients scheduled for continuous intracranial pressure monitoring
Not Eligible

You will not qualify if you...

  • Significant media opacity preventing retinal vein imaging and video capture in both eyes
  • Current or previous glaucoma, glaucoma suspect, or non-glaucoma optic neuropathy in both eyes
  • Retinal vein or artery occlusions in both eyes (branch or central)
  • Active or history of proliferative diabetic retinopathy or diabetic papillitis in both eyes
  • Symptoms or signs suggesting possible raised intracranial pressure
  • Current or past disorders affecting intracranial pressure including idiopathic intracranial hypertension, hydrocephalus, epilepsy, intracranial bleeds, tumors, traumatic brain injury, CNS inflammatory or infectious disorders, congenital neuro-cranial disorders, neurosurgical or interventional procedures (except radiologically confirmed ischemic stroke without subsequent hemorrhage or neurosurgery)
  • Current or recent (within 6 months) use of medications affecting intracranial pressure such as steroids, vitamin A analogues, tetracyclines, recombinant growth hormone, lithium, nitrofurantoin, nalidixic acid, sulfenazone, cyclosporine, or amiodarone
  • Bed-bound patients
  • Patients unable or unwilling to provide written informed consent or undergo study procedures as determined by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

King's Ophthalmology Research Unit

London, London, United Kingdom, SE5 9RS

Actively Recruiting

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Research Team

K

King's Ophthalmology Research Unit

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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