Actively Recruiting
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
N/A
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
Researchers are collecting images and videos of the spontaneous venous pulsation (SVP) seen at the back of the eye to develop a software tool that can detect this pulse automatically. This pulse, seen in most people with normal brain pressure, tends to disappear when the pressure around the brain rises, which can happen due to various conditions like tumours, swelling, or trauma. The study aims to use these images and videos from both healthy individuals and patients suspected of having raised brain pressure to help estimate brain pressure without invasive tests.
CONDITIONS
Brief Title
Prospective Ocular Imaging for Intracranial Pressure Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Healthy controls undergoing routine mydriatic ophthalmology OCT scans with presumed normal intracranial pressure
- Patients due to undergo lumbar puncture with measurement of cerebrospinal fluid pressures
- Patients due to undergo continuous intracranial pressure monitoring
You will not qualify if you...
- Significant eye conditions restricting imaging in both eyes
- Current or previous glaucoma or glaucoma suspect in both eyes, or family history of glaucoma in a first-degree relative
- Retinal vein or artery occlusions in both eyes
- Active or history of proliferative diabetic retinopathy or diabetic papillitis in both eyes
- Symptoms or signs suggesting possible raised intracranial pressure in healthy controls
- History of disorders affecting intracranial pressure such as idiopathic intracranial hypertension, hydrocephalus, epilepsy, intracranial bleeds, tumours, traumatic brain injury, CNS inflammatory or infectious disorders, congenital neuro-cranial disorders, or neurosurgical procedures
- Use of medications affecting intracranial pressure within the last 6 months
- Bed-bound patients
- Individuals unwilling or unable to provide written informed consent or undergo the testing procedures as described in the protocol
- For patients undergoing lumbar puncture or pressure monitoring: current or previous glaucoma or glaucoma suspect in both eyes, retinal vein or artery occlusions in both eyes, bed-bound status, or inability to consent or undergo procedures as described
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment to last study visit (up to 12 months)
Participants undergo ocular imaging including OCT scans and fundus video capture to detect and quantify spontaneous venous pulsations (SVPs) as a non-invasive method to evaluate intracranial pressure.
1 baseline visit and up to 3 additional optional visits
Duration - Up to 12 months
Participants are optionally monitored with additional visits within 12 months to collect longitudinal imaging and clinical data for the development of automated tools to estimate intracranial pressure.
Up to 3 follow-up visits
Trial Site Locations
Total: 1 location
1
King's Ophthalmology Research Unit
London, London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
K
King's Ophthalmology Research Unit
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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