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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

897 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.

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Detailed Description

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This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.

Conditions

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Primary Open Angle Glaucoma (POAG) Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CyPass Micro-Stent + Cataract Surgery

Subjects receive the CyPass Micro-Stent at the conclusion of their cataract surgery

Group Type EXPERIMENTAL

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.

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 to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.

Cataract Surgery Only

Subjects do not receive the CyPass Micro-Stent at the conclusion of their cataract surgery

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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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

CyPass Micro-Stent

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary open angle glaucoma (POAG)
* Mean diurnal unmedicated IOP of 21 - 33 mmHg
* Normal anterior chamber angle anatomy at site of implantation
* Operable age-related cataract

Exclusion Criteria

* Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
* Significant risk associated with washout of ocular hypotensive medication
* Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
* Previous corneal surgery
* Clinically significant ocular pathology, other than cataract and glaucoma
* Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No