Clinical trial NCT01052558: GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
Official title: A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Keywords: Open angle
Glaucoma
Cataract
Surgery
Intraocular Pressure
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.

Detailed description: Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with open-angle glaucoma in the study eye
* Subject must be on 1 to 3 glaucoma medications
* Subject able and willing to attend follow up visits for two years postop
* Subject able and willing to sign informed consent

Exclusion Criteria:

* Pseudoexfoliative and pigmentary glaucoma
* Prior glaucoma surgery of any type

Primary outcomes:
measure: Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Boozman-Hof Regional Eye Clinic
state: Arkansas
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Parker
country: United States
facility: Glaucoma Consultants of Colorado
state: Colorado
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 / Eye Care Centers Management, Inc.
state: Georgia
city: Chicago
country: United States
facility: Chicago Eye Specialists
state: Illinois
city: Indianapolis
country: United States
facility: Whitson Vision, PC
state: Indiana
city: Lancaster
country: United States
facility: D'Ambrosio Eye Care
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Physician Research Group
state: Nevada
city: Las Vegas
country: United States
facility: Shepherd Eye Center
state: Nevada
city: Rockville Center
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Charlotte
country: United States
facility: Thomas Mundorf, MD
state: North Carolina
city: Brookville
country: United States
facility: Laurel Eye Clinic
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Carolina Eyecare Physicians
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision / Sanford Clinic
state: South Dakota
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Nacogdoches
country: United States
facility: Lehmann Eye Center
state: Texas
Study officials:
affiliation: Glaukos Corporation
name: Jeff Wells, PharmD, MBA
role: STUDY_DIRECTOR
affiliation: Wills Eye Institute; Thomas Jefferson University
name: Jay Katz, MD
role: STUDY_CHAIR
References: