Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery

Conditions
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Open-angle Glaucoma

Intervention / Treatment
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* Device: Glaucoma Stent Surgery (GTS400 Stent)
* Procedure: cataract surgery alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery | Device: Glaucoma Stent Surgery (GTS400 Stent)<br>* ab interno trabecular bypass stent surgery<br>* Other names: GTS400 Stent;|
| Placebo Comparator: 2<br>Control Group (Group 2): Cataract surgery only | Procedure: cataract surgery alone<br>* Cataract surgery alone<br>* Other names: Phacoemulsification;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications | Percent reaching this endpoint | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open angle, Glaucoma, Cataract, Surgery