GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
- Conditions
- Glaucoma
- Interventions
- Procedure: Cataract SurgeryDevice: iStent Inject (GTS400)
- Registration Number
- NCT01052558
- Lead Sponsor
- Glaukos Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- 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
- Pseudoexfoliative and pigmentary glaucoma
- Prior glaucoma surgery of any type
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cataract Surgery Only Cataract Surgery - Treatment with Cataract Surgery & Stents iStent Inject (GTS400) Ab interno trabecular micro-bypass stent surgery
- Primary Outcome Measures
Name Time Method Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit. 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
St. John's Medical Research Institute
🇺🇸Springfield, Missouri, United States
Las Vegas Physician Research Group
🇺🇸Henderson, Nevada, United States
Chicago Eye Specialists
🇺🇸Chicago, Illinois, United States
Whitson Vision, PC
🇺🇸Indianapolis, Indiana, United States
Ophthalmic Consultants of Long Island
🇺🇸Rockville Center, New York, United States
Shepherd Eye Center
🇺🇸Las Vegas, Nevada, United States
Thomas Mundorf, MD
🇺🇸Charlotte, North Carolina, United States
Boozman-Hof Regional Eye Clinic
🇺🇸Rogers, Arkansas, United States
North Bay Eye Associates, Inc.
🇺🇸Petaluma, California, United States
The Center for Excellence in Eye Care
🇺🇸Miami, Florida, United States
Laurel Eye Clinic
🇺🇸Brookville, Pennsylvania, United States
Carolina Eyecare Physicians
🇺🇸Mt. Pleasant, South Carolina, United States
Vance Thompson Vision / Sanford Clinic
🇺🇸Sioux Falls, South Dakota, United States
Glaucoma Consultants of Colorado
🇺🇸Parker, Colorado, United States
Texan Eye
🇺🇸Austin, Texas, United States
Lehmann Eye Center
🇺🇸Nacogdoches, Texas, United States
International Eye Center
🇺🇸Tampa, Florida, United States
Clayton Eye Center / Eye Care Centers Management, Inc.
🇺🇸Morrow, Georgia, United States
D'Ambrosio Eye Care
🇺🇸Lancaster, Massachusetts, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Discover Vision Centers
🇺🇸Independence, Missouri, United States
Silverstein Eye Centers
🇺🇸Kansas City, Missouri, United States