Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00721968
First received: July 23, 2008
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.


Condition Intervention Phase
Open-angle Glaucoma
Device: Glaucoma Stent Surgery (GTS400 Stent)
Procedure: cataract surgery alone
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 Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percent reaching this endpoint


Other Outcome Measures:
  • Number of Ocular Hypotensive Medications by Visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: March 2007
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
Device: Glaucoma Stent Surgery (GTS400 Stent)
ab interno trabecular bypass stent surgery
Other Name: GTS400 Stent
Placebo Comparator: 2
Control Group (Group 2): Cataract surgery only
Procedure: cataract surgery alone
Cataract surgery alone
Other Name: Phacoemulsification

Detailed Description:

The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
  • Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

Not meeting inclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721968

Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Head of Clinical Affairs Glaukos Corporation
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00721968     History of Changes
Other Study ID Numbers: GC-005
Study First Received: July 23, 2008
Results First Received: April 18, 2013
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery

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

ClinicalTrials.gov processed this record on August 28, 2014