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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

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 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

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



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 ]


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

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


  Hide Study Locations
Locations
United States, Arizona
Glendale, Arizona, United States, 85306
United States, Arkansas
Fayetteville, Arkansas, United States, 72704
United States, California
La Jolla, California, United States, 92037
Murrieta, California, United States, 92562
Petaluma, California, United States, 94954
Redding, California, United States, 96002
Santa Rosa, California, United States, 95401
United States, Colorado
Fort Collins, Colorado, United States, 80525
Parker, Colorado, United States, 80134
United States, Connecticut
Fairfield, Connecticut, United States, 06824
United States, Florida
Cape Coral, Florida, United States, 33904
Miami, Florida, United States, 33176
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33603
United States, Georgia
Morrow, Georgia, United States, 30260
United States, Illinois
Chicago, Illinois, United States, 60619
Homewood, Illinois, United States, 60430
United States, Kansas
Overland Park, Kansas, United States, 66213
United States, Maryland
Baltimore, Maryland, United States, 21287
Bowie, Maryland, United States, 20716
United States, Massachusetts
Lancaster, Massachusetts, United States, 01523
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Bloomington, Minnesota, United States, 55431
United States, Missouri
Independence, Missouri, United States, 64055
Kansas City, Missouri, United States, 64133
Saint Louis, Missouri, United States, 63131
Springfield, Missouri, United States, 65807
United States, New Jersey
South Orange, New Jersey, United States, 07079
Vineland, New Jersey, United States, 08361
United States, New York
Slingerlands, New York, United States, 12159
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
Spartanburg, South Carolina, United States, 29306
United States, South Dakota
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Austin, Texas, United States, 78731
Fort Worth, Texas, United States, 76102
San Antonio, Texas, United States, 78229
United States, Virginia
Norfolk, Virginia, United States, 23502
Roanoke, Virginia, United States, 24016
United States, Washington
Spokane, Washington, United States, 99204
United States, Wisconsin
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
Glaukos Corporation

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