Prospective Ocular Imaging for Intracranial Pressure Evaluation

NCT06855342 | Recruiting

• 1 other identifier: KCH23-137 / IRAS 324282
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Intracranial Hypertension; Intracranial Pressure Increase; Spontaneous Venous Pulsations

Keywords

Spontaneous Venous Pulsations; Optic disc videography

Outcome Measures

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.

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

Secondary Outcomes (3)

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

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

• To determine the screen failure rate within the timeframe of recruitment

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

• To determine the study withdrawal rate

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

Study Arms (3)

Healthy control participants

Healthy control participants

Suspected raised intracranial pressure - due to undergo lumbar puncture

Suspected raised intracranial pressure - due to undergo lumbar puncture

Suspected raised intracranial pressure - due to undergo intracranial pressure monitoring

Suspected raised intracranial pressure - due to undergo intracranial pressure monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged ≥18 years
• Presumed normal ICP undergoing routine mydriatic ophthalmology OCT scans.

You may not qualify if:

• 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.
• Symptoms and/or signs that, in the opinion of the investigator, indicate possible raised intracranial pressure.
• Current or previous history of disorders affecting intracranial pressure including, but not limited to, idiopathic intracranial hypertension, hydrocephalus, epilepsy, intracranial bleeds, space occupying lesions or tumours, traumatic brain injury, central nervous system inflammatory or infectious disorders, congenital neuro-cranial disorders, neurosurgical or interventional procedures. Radiologically-confirmed ischaemic stroke is permissible, provided the patient did not develop a subsequent haemorrhagic stroke or require neurosurgical intervention.
• Current or recent (6 months) history of medication use affecting intracranial pressure including steroids, vitamin A analogues, tetracyclines, recombinant growth hormone, lithium, nitrofurantoin, nalidixic acid, sulfenazone, cyclosporine, amiodarone.
• Bed-bound patients.
• Patients who, in the opinion of the investigator, would be unwilling or unable to provide written informed consent, or undergo the testing procedures as described in the protocol.
• Patients due to undergo lumbar puncture or intracranial pressure bolt monitoring:
• Aged ≥18 years.
• Patients due to undergo lumbar puncture with measurement of Opening and Closing CSF pressures
• Patients due to undergo continuous ICP monitoring
• \. Current or previous evidence of glaucoma or glaucoma suspect in both eyes.
• \. Retinal vein or artery occlusions in both eyes (branch or central).

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's Ophthalmology Research Unit

London, London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

King's Ophthalmology Research Unit

CONTACT

+44 203 299 7791; kch-tr.ophthalmologyresearch@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: March 3, 2025
• Study Start: January 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-01

Locations

GB (1)