Clinical trial NCT00323284: A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
Official title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Keywords: Open angle
Glaucoma
Cataract
Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy
timeFrame: 12 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates Inc
state: California
city: Sacramento
country: United States
facility: Ellison Ambulatory Care Center
state: California
city: San Clemente
country: United States
facility: Harvard Eye Associates
state: California
city: Santa Maria
country: United States
facility: Shepard Eye Center
state: California
city: Littleton
country: United States
facility: Glaucoma Consultants of Colorado
state: Colorado
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
city: Tampa
country: United States
facility: International Eye Center
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence
state: Kansas
city: Louisville
country: United States
facility: The Eye Care Institute Building
state: Kentucky
city: Baton Rouge
country: United States
facility: Williamson Nelson Eye Center
state: Louisiana
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Edina
country: United States
facility: Chu Vision Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Las Vegas
country: United States
facility: The Shepherd Eye Center
state: Nevada
city: Slingerlands
country: United States
facility: Glaucoma Consultants of Capital Region
state: New York
city: Greensboro
country: United States
facility: Donald J. Digby and Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: James Branch MD
state: North Carolina
city: Cincinnati
country: United States
facility: Cinicinnati Eye Institute
state: Ohio
city: Brookville
country: United States
facility: Laurel Eye Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
city: Beaumont
country: United States
facility: Southeast Texas Medical Association, L.L.P.
state: Texas
Study officials:
affiliation: Glaukos Corporation
name: Jeff Wells, PharmD, MBA
role: STUDY_DIRECTOR
References:
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/j.ophtha.2010.07.007. Epub 2010 Sep 15.
citation: 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. doi: 10.1016/j.jcrs.2012.03.025.