Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2015 by Glaukos Corporation.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01461291

First Posted: October 28, 2011

Last Update Posted: October 26, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Glaukos Corporation

Purpose

Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Condition	Intervention	Phase
Primary Open-angle Glaucoma	Device: iStent inject Procedure: Cataract surgery	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ]

Secondary Outcome Measures:

Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ]


Estimated Enrollment:	1200
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	July 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject	Device: iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject
Active Comparator: Cataract surgery Cataract surgery alone	Procedure: Cataract surgery Cataract surgery alone

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild to moderate open-angle glaucoma
Characteristics consistent with mild/moderate glaucoma
Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

Pigmentary or pseudoexfoliative glaucoma
Prior incisional glaucoma surgery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461291

Show 43 Study Locations

Sponsors and Collaborators

Glaukos Corporation

More Information


Responsible Party:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT01461291 History of Changes
Other Study ID Numbers:	GC-008
First Submitted:	October 25, 2011
First Posted:	October 28, 2011
Last Update Posted:	October 26, 2015
Last Verified:	October 2015

Keywords provided by Glaukos Corporation:


Primary open-angle glaucoma POAG Trabecular meshwork iStent inject

Additional relevant MeSH terms:


Glaucoma Cataract Glaucoma, Open-Angle	Ocular Hypertension Eye Diseases Lens Diseases

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