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Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

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ClinicalTrials.gov Identifier: NCT00721968
Recruitment Status : Completed
First Posted : July 25, 2008
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Open-angle Glaucoma Device: Glaucoma Stent Surgery (GTS400 Stent) Procedure: cataract surgery alone Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications [ Time Frame: 12 months ]
    Percent reaching this endpoint


Other Outcome Measures:
  1. Number of Ocular Hypotensive Medications by Visit [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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


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 ClinicalTrials.gov identifier (NCT number): NCT00721968


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

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00721968     History of Changes
Other Study ID Numbers: GC-005
First Posted: July 25, 2008    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014
Last Verified: February 2014

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery

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