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

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma	Device: iStent plus Cataract Surgery Procedure: Cataract surgery only	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma High Blood Pressure

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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:

Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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

Enrollment:	240
Study Start Date:	June 2005
Study Completion Date:	March 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A--iStent plus Cataract Surgery iStent plus Cataract Surgery	Device: iStent plus Cataract Surgery ab interno trabecular bypass stent surgery Other Name: iStent Surgery
Active Comparator: B--Cataract Surgery Only Cataract Surgery only	Procedure: Cataract surgery only Cataract surgery only Other Name: Phacoemulsification

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323284

Show 31 Study Locations

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Director:

Jeff Wells, PharmD, MBA

Glaukos Corporation

More Information

Publications:

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. Epub 2010 Sep 15.

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(8):1339-45.

Responsible Party:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT00323284 History of Changes
Other Study ID Numbers:	GC-003
Study First Received:	May 6, 2006
Results First Received:	September 4, 2012
Last Updated:	September 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Glaukos Corporation:

Open angle
Glaucoma
Cataract
Surgery

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Cataract

Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 16, 2013