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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Conditions

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Open-Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

iStent

Intervention Type DEVICE

Glaucoma Surgery

Interventions

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iStent

Glaucoma Surgery

Intervention Type DEVICE

Other Intervention Names

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Glaukos iStent

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on at least one glaucoma medication
* Patient requiring cataract surgery and an intraocular lens implantation

Exclusion Criteria

* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
* Angle closure glaucoma

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No