A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial — COMPASS-XT

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Glaucoma
Glaucoma, Open-Angle
Primary Open Angle Glaucoma (POAG)

Clinical Trial Details

NCT number	NCT02700984
Study type	Interventional
Source	Alcon Research
Contact
Status	Completed
Phase	N/A
Start date	March 30, 2016
Completion date	April 18, 2018

View Details

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