Evaluating eye images to assess brain pressure

Prospective Ocular Imaging for Intracranial Pressure Evaluation

This study is testing a new way to see if eye images can help tell if someone has high pressure in their brain, using a non-invasive method that could be safer than current techniques.

Quick facts

• Study type: Observational
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King's College Hospital NHS Trust (Academic / other)
• Locations: 1 site (London, London)
• Trial ID: NCT06855342 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect high-quality images and videos of spontaneous venous pulsations at the back of the eye to evaluate intracranial pressure (ICP). It will involve two groups of participants: those with normal ICP and those suspected of having elevated ICP. The goal is to develop a software tool that can automatically detect these pulsations, which may disappear in cases of raised ICP. This non-invasive method could provide a safer alternative to traditional invasive ICP measurement techniques.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 and older undergoing routine ophthalmology scans with presumed normal ICP.

Not a fit: Patients with known or suspected intracranial pressure issues or significant eye conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer, non-invasive methods for assessing intracranial pressure, reducing the need for invasive procedures.

How similar studies have performed: While non-invasive methods for ICP evaluation are being explored, this specific approach using ocular imaging is relatively novel and has not been extensively tested.

Eligibility criteria

Healthy controls:

Inclusion Criteria:

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

Exclusion Criteria:

1. Significant media opacity restricting acquisition of retinal vein imaging and video capture in both eyes.
2. 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.
3. Retinal vein or artery occlusions in both eyes (branch or central).
4. Active or history of proliferative diabetic retinopathy, or diabetic papillitis in both eyes.
5. Symptoms and/or signs that, in the opinion of the investigator, indicate possible raised intracranial pressure.
6. 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.
7. 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.
8. Bed-bound patients.
9. 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:

Inclusion:

1. Aged ≥18 years.
2. Patients due to undergo lumbar puncture with measurement of Opening and Closing CSF pressures
3. Patients due to undergo continuous ICP monitoring

Exclusion:

2\. Current or previous evidence of glaucoma or glaucoma suspect in both eyes.

3\. Retinal vein or artery occlusions in both eyes (branch or central).

4\. Bed-bound patients.

5\. 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.

Where this trial is running

London, London

• King's Ophthalmology Research Unit — London, London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: King's Ophthalmology Research Unit

Conditions Idiopathic Intracranial Hypertension; Intracranial Pressure Increase; Spontaneous Venous Pulsations; Optic disc videography