Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615661
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
A Real-World Evidence Study of Goniotomy with the C-REX Instrument in Patients with Primary Open Angle Glaucoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients with Primary Open Angle Glaucoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCLE
Brief Summary:
This study enrolls adults with primary open angle glaucoma POAG who underwent goniotomy intraocular pressure IOP-lowering surgery with the C-Rex Instrument Patients are consented prior to surgery and followed for 12 months postoperatively Data regarding IOP use of glaucoma medications and any device-related complications are collected during the study time period
Detailed Description:
This a multicenter observational real-world evidence study of eligible adults with primary open angle glaucoma POAG in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed
Data is collected from the preoperative visits that directly preceded the surgery the surgical procedure and post-surgical visits through 12 months postoperatively
Specific data collected includes C-Rex Instrument goniotomy surgical details preoperative and postoperative IOP and use of ocular hypotensive medications and device-related safety events
Data is collected from the preoperative visits that directly preceded the surgery the surgical procedure and post-surgical visits through 12 months postoperatively
Specific data collected includes C-Rex Instrument goniotomy surgical details preoperative and postoperative IOP and use of ocular hypotensive medications and device-related safety events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None