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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01052558
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : May 19, 2015
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

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 Name: Cataract surgery, stent implantation

Primary Outcome Measures :
  1. Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01052558

  Show 22 Study Locations
Sponsors and Collaborators
Glaukos Corporation
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
Study Chair: Jay Katz, MD Wills Eye Institute; Thomas Jefferson University

Responsible Party: Glaukos Corporation Identifier: NCT01052558     History of Changes
Other Study ID Numbers: GC-006
First Posted: January 20, 2010    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Glaukos Corporation:
Open angle
Intraocular Pressure

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Lens Diseases