Prospective Ocular Imaging for Intracranial Pressure Evaluation

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Prospective Ocular Imaging for Intracranial Pressure Evaluation," is studying how to use pictures and videos of the back of the eye to help understand brain pressure levels. In people with normal brain pressure, there is a visible pulse in the blood vessels around the optic nerve at the back of the eye. However, this pulse disappears when the brain pressure is too high, which can happen for various reasons, such as tumors or injuries. The researchers are trying to find out if high-quality images taken with different types of machines can help create a computer program that automatically detects this pulse. This could potentially allow doctors to estimate brain pressure without needing invasive procedures like spinal taps, which involve inserting needles.

To participate in the study, you need to be at least 18 years old. There are two groups of people they are looking for: healthy individuals who are getting routine eye scans and patients who are scheduled for procedures to measure their brain pressure. Some health conditions, such as glaucoma or certain eye disorders, may prevent someone from joining the trial. If you are eligible, you can expect to have your eyes examined with these special imaging tools, which is generally safe and non-invasive. Overall, this study aims to find a better way to assess brain pressure, which could improve patient care and reduce the need for more risky tests.

Gender

ALL

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.