Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery



Status:Active, not recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:8/2/2018
Start Date:July 2013
End Date:July 2021

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A Prospective, Controlled, Multicenter Post-Approval Study Of The Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery

The purpose of this study is to assess the long-term safety of the Glaukos® iStent®
Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery vs. cataract
surgery only, in subjects with mild to moderate open-angle glaucoma.

The purpose of this study is to assess the long-term safety of the Glaukos® iStent®
Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery compared to
cataract surgery only, in subjects with mild to moderate open-angle glaucoma.

Inclusion Criteria:

- mild to moderate primary open-angle glaucoma

- currently treated with ocular hypotensive medication

- pseudoexfoliative and pigmentary glaucoma are acceptable diagnoses

- subject scheduled to undergo cataract surgery

Exclusion Criteria:

- primary angle-closure glaucoma; or secondary angle closure glaucoma, including
neovascular glaucoma

- retrobulbar tumor, thyroid eye disease, Sturge-Weber syndrome or any other type of
condition that may cause elevated episcleral venous pressure
We found this trial at
15
sites
Atlanta, Georgia
Phone: 949-367-9600
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Aurora, Colorado 80045
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Cincinnati, Ohio
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Cincinnati, OH
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Edgewood, Kentucky
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Edgewood, KY
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Irvine, California 92697
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Irvine, CA
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Jackson, Michigan
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Jackson, MI
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Kansas City, Missouri 64108
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Kansas City, MO
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Kingston, Pennsylvania 18704
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Kingston, PA
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Louisville, Kentucky 40202
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Louisville, KY
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Mentor, Ohio 44060
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Mentor, OH
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Montebello, California 90640
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Montebello, CA
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Saint Joseph, Michigan
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Saint Joseph, MI
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Winston-Salem, North Carolina
Phone: 949-367-9600
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Winston-Salem, NC
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