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

2016-03-08 02:38:22 | BioPortfolio


This is an observational study involving patients who completed the COMPASS Trial, in which the Transcend Medical CyPass Micro-Stent was evaluated through 2 years postoperatively . In the COMPASS-XT study, clinical data will be collected on participating subjects for an additional 3 years.


The COMPASS Trial 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 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 3, 4 and 5 years postoperatively for a total of 5 year follow-up across the 2 studies.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Primary Open Angle Glaucoma (POAG)


CyPass Micro-Stent, Cataract Surgery


George R. Reiss, MD
United States


Enrolling by invitation


Transcend Medical, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2016-03-08T02:38:22-0500

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