GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
NCT ID: NCT01052558
Last Updated: 2015-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
164 participants
INTERVENTIONAL
2010-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cataract Surgery Only
Cataract Surgery
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
Treatment with Cataract Surgery & Stents
Ab interno trabecular micro-bypass stent surgery
iStent Inject (GTS400)
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
Interventions
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iStent Inject (GTS400)
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.
Cataract Surgery
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject must be on 1 to 3 glaucoma medications
* Subject able and willing to attend follow up visits for two years postop
* Subject able and willing to sign informed consent
Exclusion Criteria
* Prior glaucoma surgery of any type
18 Years
90 Years
ALL
No
Sponsors
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Glaukos Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Wells, PharmD, MBA
Role: STUDY_DIRECTOR
Glaukos Corporation
Jay Katz, MD
Role: STUDY_CHAIR
Wills Eye Institute; Thomas Jefferson University
Locations
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Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Glaucoma Consultants of Colorado
Parker, Colorado, United States
The Center for Excellence in Eye Care
Miami, Florida, United States
International Eye Center
Tampa, Florida, United States
Clayton Eye Center / Eye Care Centers Management, Inc.
Morrow, Georgia, United States
Chicago Eye Specialists
Chicago, Illinois, United States
Whitson Vision, PC
Indianapolis, Indiana, United States
D'Ambrosio Eye Care
Lancaster, Massachusetts, United States
Kresge Eye Institute
Detroit, Michigan, United States
Discover Vision Centers
Independence, Missouri, United States
Silverstein Eye Centers
Kansas City, Missouri, United States
St. John's Medical Research Institute
Springfield, Missouri, United States
Las Vegas Physician Research Group
Henderson, Nevada, United States
Shepherd Eye Center
Las Vegas, Nevada, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Thomas Mundorf, MD
Charlotte, North Carolina, United States
Laurel Eye Clinic
Brookville, Pennsylvania, United States
Carolina Eyecare Physicians
Mt. Pleasant, South Carolina, United States
Vance Thompson Vision / Sanford Clinic
Sioux Falls, South Dakota, United States
Texan Eye
Austin, Texas, United States
Lehmann Eye Center
Nacogdoches, Texas, United States
Countries
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Other Identifiers
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GC-006
Identifier Type: -
Identifier Source: org_study_id
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