Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-24
Brief Title:
ICP Outflow Study
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
The Relationship Between Intracranial Pressure and Aqueous Outflow in Idiopathic Intracranial Hypertension
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate the relationship between intracranial pressure ICP and aqueous outflow the flow of the eyes 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
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
Detailed Description:
This study aims to investigate the relationship between intracranial pressure ICP and aqueous outflow the flow of the eyes internal fluid out of the eye in patients with increased intracranial pressure idiopathic intracranial hypertension IIH
The effect of lowering intracranial pressure on aqueous outflow will be examined by taking additional measurements before and after a procedure called a lumbar puncture LP These measurements include a scan to measure the dimensions of the eye intraocular pressure reading and a non-invasive technique to measure aqueous outflow electronic Schiotz tonography which is used regularly in the eye research unit at St Thomas Hospital
Study participants will already be scheduled for a lumbar puncture as they have known or suspected IIH and LP is routinely used to investigate this Additionally control participants having LP for reasons not pertaining to a condition that may elevate intracranial pressure will also be included Study participants will finish their involvement following the second aqueous outflow reading after their LP
A lumbar puncture procedure directly measures the intracranial pressure but also reduces the pressure in the process If aqueous outflow is measured before and after lumbar puncture it will provide more information about whether the change in intracranial pressure affects the intraocular pressure due to a change in the rate of fluid flowing out of the eye If a relationship between intracranial pressure and aqueous outflow is found to be present it may offer an alternative non-invasive measurement for intracranial pressure Additionally this study would highlight an avenue of investigation into dysregulation of intraocular pressure in conditions such as glaucoma Similarly negative findings would help inform ongoing discussions and controversies in the literature regarding relationships between intraocular pressure and intracranial pressure
The effect of lowering intracranial pressure on aqueous outflow will be examined by taking additional measurements before and after a procedure called a lumbar puncture LP These measurements include a scan to measure the dimensions of the eye intraocular pressure reading and a non-invasive technique to measure aqueous outflow electronic Schiotz tonography which is used regularly in the eye research unit at St Thomas Hospital
Study participants will already be scheduled for a lumbar puncture as they have known or suspected IIH and LP is routinely used to investigate this Additionally control participants having LP for reasons not pertaining to a condition that may elevate intracranial pressure will also be included Study participants will finish their involvement following the second aqueous outflow reading after their LP
A lumbar puncture procedure directly measures the intracranial pressure but also reduces the pressure in the process If aqueous outflow is measured before and after lumbar puncture it will provide more information about whether the change in intracranial pressure affects the intraocular pressure due to a change in the rate of fluid flowing out of the eye If a relationship between intracranial pressure and aqueous outflow is found to be present it may offer an alternative non-invasive measurement for intracranial pressure Additionally this study would highlight an avenue of investigation into dysregulation of intraocular pressure in conditions such as glaucoma Similarly negative findings would help inform ongoing discussions and controversies in the literature regarding relationships between intraocular pressure and intracranial pressure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None