Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-29 @ 6:37 AM
Study NCT ID:
NCT01085357
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2010-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
Sponsor:
Transcend Medical, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Comparative, MultiCenter Clinical Study to Assess the Safety and Effectiveness of the Transcend CyPass Glaucoma Implant in Patients With Open Angle Glaucoma Undergoing Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2017-05
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:
COMPASS
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.
Detailed Description:
This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.
Study Oversight
Has Oversight DMC:
True
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?: