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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.
Observational Model: Case Control, Time Perspective: Prospective
Primary Open Angle Glaucoma (POAG)
CyPass Micro-Stent, Cataract Surgery
George R. Reiss, MD
Enrolling by invitation
Transcend Medical, Inc.
Published on BioPortfolio: 2016-03-08T02:38:22-0500
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To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.
To test the hypothesis that cataract surgery slows the apparent rate of visual field (VF) decay in primary open-angle glaucoma patients compared with rates measured during cataract progression.
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Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.
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Changing an operative procedure from an endoscopic surgical procedure to an open approach during the INTRAOPERATIVE PERIOD.
A cloprostenol derivative that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.
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