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

Phase 3

Completed

• Conditions: Open-Angle Glaucoma

• Registration Number: NCT00323284
• Lead Sponsor: Glaukos Corporation

Brief Summary

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.

Detailed Description

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. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-05-06
• Study First Submitted QC: 2006-05-06
• Study First Posted: 2006-05-09
• Primary Completion: 2009-07
• Study Completion: 2010-03
• Results First Submitted: 2012-09-04
• Results First Submitted QC: 2012-09-04
• Results First Posted: 2012-10-04
• Status Verified: 2016-03
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds	12 months	Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months

Secondary Outcome Measures

Name	Time	Method
Efficacy	12 months	Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months

Trial Locations

Locations (31)

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

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