ICP & Outflow Study (NCT06436820) | Clinical Trial Compass
UnknownNot Applicable
ICP & Outflow Study
66 participantsStarted 2024-06
Plain-language summary
This study aims to investigate the relationship between intracranial pressure (ICP) and aqueous outflow (the flow of the eye's internal fluid out of the eye), in patients with increased intracranial pressure (idiopathic intracranial hypertension (IIH)).
Through observing changes in aqueous outflow facility in patients scheduled for lumbar Puncture (LP) as part of their routine care the objectives we aim to answer include:
* Investigating the effect of lumbar puncture induced reduction in ICP on patients with known or suspected IIH, compared to control patients, who will be receiving LP for reasons not pertaining to high pressure.
* Comparing pre lumbar puncture aqueous outflow facility between patients with idiopathic intracranial hypertension and control patients.
Outside of the standard care provided for these patients as part of their scheduled lumbar puncture, they will have measurements of their eye taken before and after their lumbar puncture.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males or female between the ages of 18 and 80 (inclusive).
* Able to understand the study and give informed consent.
* Willing, able and available to participate in all aspects of the study.
* Able to undergo accurate tonography.
* Diagnosis of Idiopathic intracranial hypertension (IIH) or suspected diagnosis of IIH as determined by a consultant subspecialist neurologist or neuro-ophthalmologist.
Control group will only include:
* Individuals requiring lumbar puncture as part of their standard care for reasons other than suspected raised intracranial pressure e.g. for cerebrospinal fluid (CSF) sampling to analyse oligoclonal bands or other conditions necessitating lumbar puncture for diagnostic/prognostic purposes.
* Individuals suspected of having a raised intracranial pressure but, upon measurement of the opening pressure, are found to have an intracranial pressure within normal limits.\*
* In this study, where there are considered to be signs of raised intracranial pressure as judged by a consultant neuro ophthalmologist or neurologist, in combination with an opening CSF pressure 20cmH2O or greater, this will be taken as a raised intracranial pressure. Normal CSF pressure is taken as 19cmH2O or lower. In asymptomatic patients, pressures of up to 25cmH2O will be considered normal.
Exclusion Criteria
* Under 18 or over 80 years of age.
* Diagnosis of ocular hypertension (ocular hypertension is defined as any individual with an intraocular pressu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measure the effect of LP induced change in intracranial pressure on outflow facility in patients with idiopathic intracranial hypertension compared to control patients