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

Sponsor

Glaukos Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01052558

Collaborator

(none)

164

Enrollment

Locations

Arms

Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: iStent Inject (GTS400) Procedure: Cataract Surgery	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cataract Surgery Only	Procedure: Cataract Surgery Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
Experimental: Treatment with Cataract Surgery & Stents Ab interno trabecular micro-bypass stent surgery	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. Other Names: Cataract surgery, stent implantation

Arm

Intervention/Treatment

Active Comparator: Cataract Surgery Only

Procedure: Cataract Surgery

Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.

Experimental: Treatment with Cataract Surgery & Stents

Ab interno trabecular micro-bypass stent surgery

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.

Other Names:

Cataract surgery, stent implantation

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boozman-Hof Regional Eye Clinic	Rogers	Arkansas	United States	72756
2	North Bay Eye Associates, Inc.	Petaluma	California	United States	94954
3	Glaucoma Consultants of Colorado	Parker	Colorado	United States	80134
4	The Center for Excellence in Eye Care	Miami	Florida	United States	33176
5	International Eye Center	Tampa	Florida	United States	33603
6	Clayton Eye Center / Eye Care Centers Management, Inc.	Morrow	Georgia	United States	30260
7	Chicago Eye Specialists	Chicago	Illinois	United States	60619
8	Whitson Vision, PC	Indianapolis	Indiana	United States	46240
9	D'Ambrosio Eye Care	Lancaster	Massachusetts	United States	01523
10	Kresge Eye Institute	Detroit	Michigan	United States	48201
11	Discover Vision Centers	Independence	Missouri	United States	64055
12	Silverstein Eye Centers	Kansas City	Missouri	United States	64133
13	St. John's Medical Research Institute	Springfield	Missouri	United States	65807
14	Las Vegas Physician Research Group	Henderson	Nevada	United States	75965
15	Shepherd Eye Center	Las Vegas	Nevada	United States	89121
16	Ophthalmic Consultants of Long Island	Rockville Center	New York	United States	11570
17	Thomas Mundorf, MD	Charlotte	North Carolina	United States	28204
18	Laurel Eye Clinic	Brookville	Pennsylvania	United States	15825
19	Carolina Eyecare Physicians	Mt. Pleasant	South Carolina	United States	29464
20	Vance Thompson Vision / Sanford Clinic	Sioux Falls	South Dakota	United States	57105
21	Texan Eye	Austin	Texas	United States	78731
22	Lehmann Eye Center	Nacogdoches	Texas	United States	75965