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

Completed · Phase 3

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01052558

Run by

Glaukos Corporation

People needed

164

Starts

2010-01-01

Expected to finish

2013-12-01

Last updated by the study team

2015-05-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with open-angle glaucoma in the study eye
• Subject must be on 1 to 3 glaucoma medications
• Subject able and willing to attend follow up visits for two years postop
• Subject able and willing to sign informed consent

You may not qualify if…

• Pseudoexfoliative and pigmentary glaucoma
• Prior glaucoma surgery of any type

Where it is running

• Boozman-Hof Regional Eye Clinic — Rogers, Arkansas, United States
• North Bay Eye Associates, Inc. — Petaluma, California, United States
• Glaucoma Consultants of Colorado — Parker, Colorado, United States
• The Center for Excellence in Eye Care — Miami, Florida, United States
• International Eye Center — Tampa, Florida, United States
• Clayton Eye Center / Eye Care Centers Management, Inc. — Morrow, Georgia, United States
• Chicago Eye Specialists — Chicago, Illinois, United States
• Whitson Vision, PC — Indianapolis, Indiana, United States
• D'Ambrosio Eye Care — Lancaster, Massachusetts, United States
• Kresge Eye Institute — Detroit, Michigan, United States
• Discover Vision Centers — Independence, Missouri, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• St. John's Medical Research Institute — Springfield, Missouri, United States
• Las Vegas Physician Research Group — Henderson, Nevada, United States
• Shepherd Eye Center — Las Vegas, Nevada, United States
• Ophthalmic Consultants of Long Island — Rockville Centre, New York, United States
• Thomas Mundorf, MD — Charlotte, North Carolina, United States
• Laurel Eye Clinic — Brookville, Pennsylvania, United States
• Carolina Eyecare Physicians — Mt. Pleasant, South Carolina, United States
• Vance Thompson Vision / Sanford Clinic — Sioux Falls, South Dakota, United States
• Texan Eye — Austin, Texas, United States
• Lehmann Eye Center — Nacogdoches, Texas, United States

Full record on ClinicalTrials.gov

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