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Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent: Extended Follow-up of the Premarket Cohort

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.
 
ClinicalTrials.gov Identifier: NCT01836042
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Study Description
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Brief Summary:
The purpose of this study is to assess the long-term safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100R/L in subjects previously enrolled in Glaukos Study GC-003.

Condition or disease
Primary Open Angle Glaucoma

Detailed Description:
The goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.
Study Design
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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort
Study Start Date : July 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
Randomized iStent
Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
Randomized cataract surgery
Cataract surgery alone, patients randomized to group
Non-randomized iStent
Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Sight-threatening Adverse Events [ Time Frame: 80 Month average ]
    The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Extended follow-up of subjects previously enrolled in Glaukos Study GC-003
Criteria

Inclusion Criteria:

  • Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study

Exclusion Criteria:

  • Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow-up study
  • Patients not previously enrolled in Glaukos Study GC-003
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): NCT01836042


Locations
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United States, California
Beverly Hills, California, United States, 90210
Petaluma, California, United States, 94954
Sacramento, California, United States, 95817
San Clemente, California, United States, 92673
Santa Maria, California, United States, 93454
United States, Colorado
Parker, Colorado, United States, 80134
United States, Florida
Boynton Beach, Florida, United States, 33426
Miami, Florida, United States, 33176
Tampa, Florida, United States, 33603
United States, Georgia
Morrow, Georgia, United States, 30260
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kansas
Overland Park, Kansas, United States, 66213
United States, Kentucky
Louisville, Kentucky, United States, 40206
United States, Louisiana
Baton Rouge, Louisiana, United States, 70806
United States, Michigan
St. Joseph, Michigan, United States, 49085
United States, Minnesota
Bloomington, Minnesota, United States, 55431
Edina, Minnesota, United States, 55435
United States, Missouri
Independence, Missouri, United States, 64055
Kansas City, Missouri, United States, 64133
United States, Nevada
Las Vegas, Nevada, United States, 89121
United States, North Carolina
Winston-Salem, North Carolina, United States, 27101
United States, Ohio
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Brookville, Pennsylvania, United States, 15825
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15122
United States, Texas
Beaumont, Texas, United States, 77702
Sponsors and Collaborators
Glaukos Corporation
Investigators
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Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
Study Chair: Jay Katz, MD Wills Eye Institute; Thomas Jefferson University
More Information
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01836042    
Other Study ID Numbers: GTS100-PAS
First Posted: April 19, 2013    Key Record Dates
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016
Keywords provided by Glaukos Corporation:
Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases