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

Open-Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323284
• Other study ID #: GC-003
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2006
• Last updated: December 14, 2017
• Start date: June 2005
• Est. completion date: March 2010

Study information

• Verified date: March 2016
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Open-Angle Glaucoma

Intervention

Device:
• iStent plus Cataract Surgery
ab interno trabecular bypass stent surgery

Procedure:
• Cataract surgery only
Cataract surgery only

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Craven ER, Katz LJ, Wells JM, Giamporcaro JE; iStent Study Group. Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up. J Cataract Refract Surg. 2012 Aug;38 — View Citation

Samuelson TW, Katz LJ, Wells JM, Duh YJ, Giamporcaro JE; US iStent Study Group. Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. doi: 10.1016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds	Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months	12 months
Secondary	Efficacy	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	12 months