Ignite Creation Date:
2024-07-17 @ 10:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495580
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-03
Brief Title:
Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Optimizing Visual Outcomes Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Assessing the function of the optic nerve is paramount during various neurosurgical procedures Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials the current existing tool provides only diffuse and delayed assessment of nerve function Here the investigators propose a prospective study involving adult patients aged 18 years and older undergoing endonasal or open cranial approaches around the optic nerves who will receive pre- and post-operative visual evaluations During surgery the optic nerve and chiasm will be stimulated and the response will be recorded in both eyes and the occipital cortex via skin electrodes The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerves integrity during open and endoscopic cranial approaches Electrophysiological readings will be acquired as is routine in the operating room by our team of experts and intraoperative findings will be correlated with post- surgical clinical outcomes Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery
Detailed Description:
Our hypothesis is that utilizing anterograde optic nerve microstimulation during open and endoscopic cranial approaches will allow for more accurate and real-time assessment of optic nerve function compared to the current standard of Visual Evoked Potentials The investigators predict that this novel approach will lead to improved intraoperative monitoring and better correlation with post- surgical clinical outcomes
The study design proposed is interventional and prospective It involves implementing a novel approach anterograde optic nerve microstimulation during surgical procedures to assess optic nerve integrity This design entails actively intervening during the surgical process to stimulate the optic nerve and record responses indicating an interventional approach
The study design proposed is interventional and prospective It involves implementing a novel approach anterograde optic nerve microstimulation during surgical procedures to assess optic nerve integrity This design entails actively intervening during the surgical process to stimulate the optic nerve and record responses indicating an interventional approach
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