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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 : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase 2 Phase 3

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 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources

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, 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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Sponsors and Collaborators
Glaukos Corporation
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01461291     History of Changes
Other Study ID Numbers: GC-008
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

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