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
sites
643
mi
from
Indianapolis, IN
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637
mi
from
Baton Rouge, LA
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570
mi
from
Beaumont, TX
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Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
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544
mi
from
Bloomington, MN
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1292
mi
from
Boynton Beach, FL
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1024
mi
from
Brookville, PA
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726
mi
from
Cincinnati, OH
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553
mi
from
Edina, MN
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206
mi
from
Independence, MO
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198
mi
from
Kansas City, MO
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971
mi
from
Las Vegas, NV
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657
mi
from
Louisville, KY
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1320
mi
from
Miami, FL
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808
mi
from
Morrow, GA
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190
mi
from
Overland Park, KS
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393
mi
from
Parker, CO
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1347
mi
from
Petaluma, CA
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1225
mi
from
Philadelphia, PA
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971
mi
from
Pittsburgh, PA
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1278
mi
from
Sacramento, CA
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1148
mi
from
San Clemente, CA
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1266
mi
from
Santa Maria, CA
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670
mi
from
St. Joseph, MI
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1117
mi
from
Tampa, FL
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976
mi
from
Winston-Salem, NC
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