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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2018-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma (POAG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cataract Surgery + CyPass

CyPass Micro-Stent implanted at the conclusion of cataract surgery (COMPASS trial)

Group Type EXPERIMENTAL

CyPass Micro-Stent

Intervention Type DEVICE

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.

Cataract Surgery

Intervention Type PROCEDURE

Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

Cataract Surgery Only

Cataract Surgery (COMPASS trial) with no CyPass Micro-Stent implantation

Group Type ACTIVE_COMPARATOR

Cataract Surgery

Intervention Type PROCEDURE

Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

Interventions

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CyPass Micro-Stent

The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.

Intervention Type DEVICE

Cataract Surgery

Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Completed the COMPASS Trial
2. Understands study requirements and is willing to follow study instructions and return for study visits

Exclusion Criteria

1. Systemic disease that would put subject health at risk and/or prevent completion of required study visits.
2. Early termination from the COMPASS Trial.

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No