Ignite Creation Date:
2025-12-18 @ 8:20 AM
Ignite Modification Date:
2025-12-23 @ 10:22 PM
Study NCT ID:
NCT05506423
Status:
None
Last Update Posted:
2025-05-06 00:00:00
First Post:
2022-08-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
Sponsor:
None
Organization:
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:
None
Status Verified Date:
2025-05
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:
CREST
Brief Summary:
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 visit(s) 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 visit(s) 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.
Detailed Description:
None
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?: