Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501716
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-30
Brief Title:
ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
I See G Superior Hypophyseal Artery Intraoperative Indocyanine Green Angiogram as a Predictor of Postoperative Visual Function After Endoscopic Endonasal Surgery
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:
Endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves ON Surgery often involves dissecting tumors from the optic nerves and its blood supply which can result in nerve damage and visual loss after surgery To date there are no reliable methods to monitor the optic nerve function during surgery and thus post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam This delay in diagnosis prevents early therapeutic measures and can result in further harm to the ON We have recently recognized that when ICG is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying SHA the ON are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery Thus ICG may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap This study will assess whether endoscopic ICG angiography before and after resection of suprasellar lesions can predict post-operative visual deficits Successful completion will provide surgeons a novel tool to assess visual function during surgery The ICG endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries
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