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

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ClinicalTrials.gov Identifier: NCT01461291
Recruitment Status : Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Primary Open-angle Glaucoma Device: iStent inject Procedure: Cataract surgery Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
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
Actual Study Start Date : November 30, 2011
Actual Primary Completion Date : August 4, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. ≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ]

Secondary Outcome Measures :
  1. Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ]

Other Outcome Measures:
  1. Safety follow-up post-PMA to be through 36 months [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
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
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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


Locations
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United States, Wisconsin
Eye Centers of Racine and Kenosha
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Glaukos Corporation
Investigators
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Study Chair: Kerry Stephens, O.D. Glaukos Corporation
More Information
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01461291    
Other Study ID Numbers: GC-008
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Keywords provided by Glaukos Corporation:
Primary open-angle glaucoma
POAG
Trabecular meshwork
iStent inject
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
 Ocular Hypertension
Eye Diseases
Lens Diseases