Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Open-angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery

Group Type ACTIVE_COMPARATOR

Glaucoma Stent Surgery (GTS400 Stent)

Intervention Type DEVICE

ab interno trabecular bypass stent surgery

2

Control Group (Group 2): Cataract surgery only

Group Type PLACEBO_COMPARATOR

cataract surgery alone

Intervention Type PROCEDURE

Cataract surgery alone

Interventions

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Glaucoma Stent Surgery (GTS400 Stent)

ab interno trabecular bypass stent surgery

Intervention Type DEVICE

cataract surgery alone

Cataract surgery alone

Intervention Type PROCEDURE

Other Intervention Names

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GTS400 Stent Phacoemulsification

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No