Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Phase 3

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Device: Glaucoma Stent Surgery (GTS400 Stent); Procedure: cataract surgery alone

• Registration Number: NCT00721968
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Primary Completion: 2012-02
• Study Completion: 2012-08
• Results First Submitted: 2013-04-18
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Results First Posted: 2014-03-06
• Last Update Posted: 2014-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glaucoma Stent Surgery (GTS400 Stent)	Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
2	cataract surgery alone	Control Group (Group 2): Cataract surgery only

Primary Outcome Measures

Name	Time	Method
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications	12 months	Percent reaching this endpoint