Prospective Ocular Imaging for Intracranial Pressure Evaluation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Aged ≥18 years

Presumed normal ICP undergoing routine mydriatic ophthalmology OCT scans.

Disqualifiers

Significant media opacity restricting acquisition of retinal vein imaging and video capture in both eyes.

Current or previous evidence of glaucoma, glaucoma suspect, family history of glaucoma in a 1st degree relative, or non-glaucoma related 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.

Trial population

Healthy controls compared to participants due to undergo lumbar puncture or intracranial pressure bolt monitoring

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 3 trial groups
Group A: Healthy control participants
Group B: Suspected raised intracranial pressure - due to undergo lumbar puncture
Group C: Suspected raised intracranial pressure - due to undergo intracranial pressure monitoring

Trial outcomes

Primary outcomes

1

• To acquire a multimodal dataset of clinical data, OCT scans and high-quality SVP fundal images and videos, to help the development of automated tools to detect and quantify SVPs.

To acquire a multimodal dataset of clinical data, OCT scans and high-quality SVP fundal images and videos, to help the development of automated tools to detect and quantify SVPs.

Time frame
From enrollment to last study visit (optional 3 additional visits within 12 months)

Secondary outcomes

1

• To determine participant recruitment rate within the time frame of recruitment

Time frame
From study activation to end of study recruitment period, expected to be 12 months
2

To determine the screen failure rate within the timeframe of recruitment

Time frame
From study activation to end of study recruitment period, expected to be 12 months
3

To determine the study withdrawal rate

Time frame
From study activation to end of study recruitment period, expected to be 12 months

Other outcomes

Sponsors and contacts

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King's College Hospital NHS Trust

Lead sponsor

King's College London

Collaborator