A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

Completed · Phase 3

Conditions studied: Open-Angle Glaucoma

In brief

The purpose of this study is to evaluate the safety and efficacy of the iStent 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

NCT00323284

Run by

Glaukos Corporation

People needed

240

Starts

2005-06-01

Expected to finish

2010-03-01

Last updated by the study team

2018-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
• Subject on at least one glaucoma medication
• Able and willing to attend follow up visits for two years post operative
• Able and willing to sign informed consent

You may not qualify if…

• Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
• Angle closure glaucoma
• Fellow eye already enrolled

Where it is running

• Assil Eye Institute — Beverly Hills, California, United States
• North Bay Eye Associates Inc — Petaluma, California, United States
• Ellison Ambulatory Care Center — Sacramento, California, United States
• Harvard Eye Associates — San Clemente, California, United States
• Shepard Eye Center — Santa Maria, California, United States
• Glaucoma Consultants of Colorado — Littleton, Colorado, United States
• Florida Eye Microsurgical Institute, Inc. — Boynton Beach, Florida, United States
• The Center for Excellence in Eye Care — Miami, Florida, United States
• International Eye Center — Tampa, Florida, United States
• Clayton Eye Center — Morrow, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Stiles Eyecare Excellence — Overland Park, Kansas, United States
• The Eye Care Institute Building — Louisville, Kentucky, United States
• Williamson Nelson Eye Center — Baton Rouge, Louisiana, United States
• Kresge Eye Institute — Detroit, Michigan, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• Chu Vision Institute — Edina, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Discover Vision Centers — Independence, Missouri, United States
• Silverstein Eye Centers — Kansas City, Missouri, United States
• The Shepherd Eye Center — Las Vegas, Nevada, United States
• Glaucoma Consultants of Capital Region — Slingerlands, New York, United States
• Donald J. Digby and Associates — Greensboro, North Carolina, United States
• James Branch MD — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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