Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443411
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
RD of Non-invasive Innovative Intracranial Waves Monitoring System for Diagnostics and Treatment Monitoring of Patients with Normal Tension Glaucoma
Sponsor:
Lithuanian University of Health Sciences
Organization:
Lithuanian University of Health Sciences
Study Overview
Official Title:
RD of Non-invasive Innovative Intracranial Waves Monitoring System for Diagnostics and Treatment Monitoring of Patients with Normal Tension Glaucoma
Status:
ENROLLING_BY_INVITATION
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:
Assessment and monitoring of intracranial pressure ICP changes are important in the management of cerebral pathologies In the eye ICP increase and decrease both correlate with optic neuropathies the former because of papilledema and the latter related to glaucoma While the relationship between ICP elevation and papilledema is well established the relationship between low ICP and glaucoma is still poorly understood So far ICP monitoring is performed invasively but this entails risks including infection spurring the study of non-invasive alternatives While none of currently methods in use can fully replace invasive techniques certain measures show great potential for specific applications In this context monitoring the intracranial pressure changes of normal tension glaucoma may lead to a better understanding of how intracranial pressure waves vary in normal tension glaucoma Treatment of normal tension glaucoma as a two-pressure disease needs periodic intracranial dynamic monitoring sessions for evaluation of treatment effectiveness and for needed corrections of treatment methodology
Project aim is to be able to monitor the missing link of intracranial dynamics of patients with normal tension glaucoma according to circadian rhythm in the morning during lunch and in the evening The opportunity to monitor ICP waves non-invasively for patients with normal tension glaucoma will be implemented for the first time by using novel non-invasive intracranial pressure waves real-time monitoring system invented by KTU team in 2022 patent applications are in the process of registration in the EU and USA
Project aim is to be able to monitor the missing link of intracranial dynamics of patients with normal tension glaucoma according to circadian rhythm in the morning during lunch and in the evening The opportunity to monitor ICP waves non-invasively for patients with normal tension glaucoma will be implemented for the first time by using novel non-invasive intracranial pressure waves real-time monitoring system invented by KTU team in 2022 patent applications are in the process of registration in the EU and USA
Detailed Description:
None
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