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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:July 2013
End Date:April 2014

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Post-approval Study of The Glaukos® iStent® Trabecular Micro-bypass Stent System In Conjunction With Cataract Surgery: Extended Follow-up of the Premarket Cohort

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.

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%.

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
We found this trial at
26
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Beverly Hills, California 90211
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Bloomington, MN
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Indianapolis, IN
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Kansas City, MO
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Las Vegas, NV
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Louisville, KY
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Miami, FL
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Morrow, GA
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Overland Park, KS
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Parker, CO
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Petaluma, CA
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Philadelphia, PA
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Santa Maria, CA
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St. Joseph, MI
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Tampa, FL
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Winston-Salem, NC
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