GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052558
• Other study ID #: GC-006
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2010
• Last updated: May 18, 2015
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Device:
• iStent Inject (GTS400)
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.

Procedure:
• Cataract Surgery
Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.

Locations

Country	Name	City	State
United States	Texan Eye	Austin	Texas
United States	Laurel Eye Clinic	Brookville	Pennsylvania
United States	Thomas Mundorf, MD	Charlotte	North Carolina
United States	Chicago Eye Specialists	Chicago	Illinois
United States	Kresge Eye Institute	Detroit	Michigan
United States	Las Vegas Physician Research Group	Henderson	Nevada
United States	Discover Vision Centers	Independence	Missouri
United States	Whitson Vision, PC	Indianapolis	Indiana
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	D'Ambrosio Eye Care	Lancaster	Massachusetts
United States	Shepherd Eye Center	Las Vegas	Nevada
United States	The Center for Excellence in Eye Care	Miami	Florida
United States	Clayton Eye Center / Eye Care Centers Management, Inc.	Morrow	Georgia
United States	Carolina Eyecare Physicians	Mt. Pleasant	South Carolina
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	Glaucoma Consultants of Colorado	Parker	Colorado
United States	North Bay Eye Associates, Inc.	Petaluma	California
United States	Ophthalmic Consultants of Long Island	Rockville Center	New York
United States	Boozman-Hof Regional Eye Clinic	Rogers	Arkansas
United States	Vance Thompson Vision / Sanford Clinic	Sioux Falls	South Dakota
United States	St. John's Medical Research Institute	Springfield	Missouri
United States	International Eye Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No