Advertisement

Topics

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

Summary

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.

Description

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

Conditions

Primary Open Angle Glaucoma (POAG)

Intervention

CyPass Micro-Stent, Cataract Surgery

Location

George R. Reiss, MD
Glendale
Arizona
United States
85306

Status

Enrolling by invitation

Source

Transcend Medical, Inc.

Results (where available)

View Results

Links

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

Clinical Trials [2549 Associated Clinical Trials listed on BioPortfolio]

Post Approval Study of the CyPass System

The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as...

Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

This study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure in patients with glaucoma who undergo cataract surgery.

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Assessing the safety and efficacy of a micro-bypass stent in combination with cataract surgery in subjects with primary angle closure. Subjects are randomized into two arms: phacoemulsific...

GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ...

A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

PubMed Articles [22004 Associated PubMed Articles listed on BioPortfolio]

Cataract Surgery and Rate of Visual Field Progression in Primary Open-Angle Glaucoma.

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.

Case series of hypotony maculopathy after CyPass insertion treated with intra-luminal suture occlusion.

The CyPass Micro-Stent (Alcon, Fort Worth, USA) is a minimally invasive glaucoma surgical (MIGS) device, implanted into the supra-choroidal space. The CyPass was FDA approved in July 2016 and CE marke...

Efficacy of cataract surgery with trabecular micro-bypass stent implantation in combined-mechanism angle closure glaucoma patients.

To evaluate the effectiveness of trabecular microbypass stent (iStent) implantation in combined mechanism glaucoma (CMG).

Intracameral Phenylephrine to Arrest Intraoperative Intraocular Bleeding: A New Technique.

Intraoperative intraocular bleeding can present a major challenge during anterior segment operations, such as cataract and glaucoma surgery. In the presence of significant intraocular bleeding, the su...

Management of cataract and glaucoma in patient with a preexisting Cypass microstent in fellow eye: January consultation #1.

Medical and Biotech [MESH] Definitions

Loss of CORNEAL ENDOTHELIUM usually following intraocular surgery (e.g., cataract surgery) or due to FUCHS' ENDOTHELIAL DYSTROPHY; ANGLE-CLOSURE GLAUCOMA; IRITIS; or aging.

Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.

Congenital open-angle glaucoma that results from dysgenesis of the angle structures accompanied by increased intraocular pressure and enlargement of the eye. Treatment is both medical and surgical.

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.

More From BioPortfolio on "A Study to Assess Long-Term Safety of the Transcend CyPass Micro-Stent in Patients Completing the COMPASS Trial"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Acute Coronary Syndromes ACS
Acute Coronary Syndromes (ACS) is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked. Treatment for acute coronary syndrome includes medicines and a procedure known as angioplasty, during which doctors inflat...

Stent
A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...


Searches Linking to this Trial