Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05506423
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-01-24
First Post:
2022-08-16
Brief Title:
Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
Sponsor:
Iantrek Inc
Organization:
Iantrek Inc
Study Overview
Official Title:
An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-01
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:
CREST
Brief Summary:
This observational study will enroll adults with open angle glaucoma OAG who had surgery to reduce intraocular pressure IOP using the CycloPen Micro-Interventional System Consenting participants will be followed for 24 months after their surgery
Data regarding IOP use of glaucoma medications and any side effects related to the surgery will be collected from participants preoperative examination their surgery and postoperative examinations
Data regarding IOP use of glaucoma medications and any side effects related to the surgery will be collected from participants preoperative examination their surgery and postoperative examinations
Detailed Description:
This is a multicenter observational registry of eligible adults with open angle glaucoma OAG in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled
Data will be collected from the preoperative visits that directly preceded surgery the surgical procedure and postoperative visits through 24 months after CycloPen System use
Specific data to be collected includes details of the CycloPen surgical procedure IOP use of ocular hypotensive medications and any side effects related to the surgery
Data will be collected from the preoperative visits that directly preceded surgery the surgical procedure and postoperative visits through 24 months after CycloPen System use
Specific data to be collected includes details of the CycloPen surgical procedure IOP use of ocular hypotensive medications and any side effects related to the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None