A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

This study has been completed.

Sponsor:

Information provided by:

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT00326040

First received: May 12, 2006

Last updated: July 23, 2008

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

May 12, 2006

Last Updated Date

July 23, 2008

Start Date ^ICMJE

April 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy
The primary effectiveness measure will be intraocular pressure evaluation from preoperative baseline
Safety
Incidence of adverse events that occur during the surgical procedure and postoperative period.

Change History

Complete list of historical versions of study NCT00326040 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Evaluation of Glaucoma medications preoperatively vs postoperatively.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

Official Title ^ICMJE

A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

Brief Summary

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

Detailed Description

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Open-Angle Glaucoma

Intervention ^ICMJE

Device: Glaucoma Surgery

Study Arm (s)

Experimental: A

Intervention: Device: Glaucoma Surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with primary open-angle glaucoma (POAG)
Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion Criteria:

Angle closure glaucoma
Fellow eye already enrolled

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Italy, Netherlands, Spain

Administrative Information

NCT Number ^ICMJE

NCT00326040

Other Study ID Numbers ^ICMJE

GC-001A

Has Data Monitoring Committee

Yes

Responsible Party

Head of Clinical Affairs, Glaukos Corporation

Study Sponsor ^ICMJE

Glaukos Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Head of Clinical Affairs

Glaukos Corporation

Information Provided By

Glaukos Corporation

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top