GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma



Status:Archived
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:January 2010
End Date:August 2013

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A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery


The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular
micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle
glaucoma or ocular hypertension and co-existing cataract.


Glaucoma is a collection of disorders characterized by progressive loss of visual field due
to optic nerve damage. It is a leading cause of blindness in the United States, affecting
1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long
treatment with a spectrum of therapeutic options including medications, laser treatment and
surgical implants. The common goal among the various therapies is to lower intraocular
pressure to target levels in order to prevent loss of visual fields from excessive pressure
on the optic nerve.


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4506 Wishart Place
Tampa, Florida 33603
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Austin, Texas 78731
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Brookville, Pennsylvania 15825
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Charlotte, North Carolina 28204
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Chicago, Illinois 60619
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Detroit, Michigan 48201
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Henderson, Nevada 75965
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Independence, Missouri 64055
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Indianapolis, Indiana 46240
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Kansas City, Missouri 64133
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Lancaster, Massachusetts 01523
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Las Vegas, Nevada 89121
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Littleton, Colorado 80120
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Lynbrook, New York 11563
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Miami, Florida 33176
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Morrow, GA
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Mt. Pleasant, South Carolina 29464
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Nacogdoches, Texas 75965
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Petaluma, California 94954
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Rogers, Arkansas 72756
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Sioux Falls, South Dakota 57105
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Springfield, Missouri 65807
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