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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01052558
First received: January 13, 2010
Last updated: September 4, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Glaucoma
 Device: iStent Inject (GTS400)
Procedure: Cataract Surgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Cataract surgery
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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052558

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

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01052558     History of Changes
Other Study ID Numbers: GC-006
Study First Received: January 13, 2010
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery
Intraocular Pressure

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Cataract
 Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on May 16, 2013