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
• Interventions: Procedure: Cataract surgery only; Device: iStent plus Cataract Surgery

• 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

Arm && Interventions

Group	Intervention	Description
B--Cataract Surgery Only	Cataract surgery only	Cataract Surgery only
A--iStent plus Cataract Surgery	iStent plus Cataract Surgery	iStent plus Cataract Surgery

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)

North Bay Eye Associates Inc; 🇺🇸 Petaluma, California, United States

Williamson Nelson Eye Center; 🇺🇸 Baton Rouge, Louisiana, United States

Clayton Eye Center; 🇺🇸 Morrow, Georgia, United States

Florida Eye Microsurgical Institute, Inc.; 🇺🇸 Boynton Beach, Florida, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States

The Shepherd Eye Center; 🇺🇸 Las Vegas, Nevada, United States

Donald J. Digby and Associates; 🇺🇸 Greensboro, North Carolina, United States

Assil Eye Institute; 🇺🇸 Beverly Hills, California, United States

Discover Vision Centers; 🇺🇸 Independence, Missouri, United States

James Branch MD; 🇺🇸 Winston-Salem, North Carolina, United States

Cinicinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States

Stiles Eyecare Excellence; 🇺🇸 Overland Park, Kansas, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Harvard Eye Associates; 🇺🇸 San Clemente, California, United States

Ellison Ambulatory Care Center; 🇺🇸 Sacramento, California, United States

Shepard Eye Center; 🇺🇸 Santa Maria, California, United States

The Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Great Lakes Eye Care; 🇺🇸 Saint Joseph, Michigan, United States

Chu Vision Institute; 🇺🇸 Edina, Minnesota, United States

Glaucoma Consultants of Capital Region; 🇺🇸 Slingerlands, New York, United States

Laurel Eye Center; 🇺🇸 Brookville, Pennsylvania, United States

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Associates in Ophthalmology; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Eye Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Southeast Texas Medical Association, L.L.P.; 🇺🇸 Beaumont, Texas, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Kresge Eye Institute; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

International Eye Center; 🇺🇸 Tampa, Florida, United States

Glaucoma Consultants of Colorado; 🇺🇸 Littleton, Colorado, United States

The Eye Care Institute Building; 🇺🇸 Louisville, Kentucky, United States