Evaluating eye images to assess brain pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: King's Ophthalmology Research Unit
• Email: kch-tr.ophthalmologyresearch@nhs.net
• Phone: +44 203 299 7791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.