Primary Open Angle Glaucoma (POAG) Clinical Trial
Official title:
An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial
The purpose of this study is to evaluate the long-term safety of the CyPass Micro-Stent in subjects who completed Study Protocol TMI-09-01, COMPASS Trial.
The COMPASS Trial (TMI-09-01) was a prospective, randomized, comparative multicenter study to assess the safety and effectiveness of the CyPass Micro-Stent in subjects with primary open angle glaucoma who were undergoing cataract surgery. In the study, 505 subjects were randomized to either the CyPass group, who underwent cataract surgery and received the CyPass Micro-Stent, or the Control group, who underwent cataract surgery alone. All subjects randomized were to be followed for 2 years postoperatively. Four hundred eighty (480) subjects completed this study. The COMPASS-XT (TMI-09-01-E) Trial is designed to collect safety data beyond 24 months postoperatively for subjects who completed the COMPASS Trial. In COMPASS-XT, clinical data will be collected at 36 months, 48 months, and 60 months postoperatively for a total of 5 year follow-up across the 2 studies. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01085357 -
Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery
|
N/A | |
Completed |
NCT02434692 -
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
|
N/A | |
Recruiting |
NCT06016972 -
Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients
|
Phase 2 | |
Completed |
NCT01517477 -
One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
|
N/A | |
Terminated |
NCT01180062 -
Safety Study of Latanoprost Slow Release Insert
|
Phase 1 | |
Terminated |
NCT03478293 -
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
|
N/A | |
Completed |
NCT01166659 -
Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy
|
N/A | |
Completed |
NCT01252849 -
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects
|
N/A | |
Active, not recruiting |
NCT00902109 -
Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients
|
N/A |