Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-22

Study Completion Date

2020-03-12

Brief Summary

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Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

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Detailed Description

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This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Conditions

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Primary Open-angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cataract surgery plus iStent supra

Group Type EXPERIMENTAL

iStent supra

Intervention Type DEVICE

Cataract surgery and implantation of one iStent supra

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery alone

Cataract surgery

Group Type ACTIVE_COMPARATOR

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery alone

Interventions

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iStent supra

Cataract surgery and implantation of one iStent supra

Intervention Type DEVICE

Cataract surgery

Cataract surgery alone

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate open-angle glaucoma
* Characteristics consistent with mild to moderate glaucoma
* Use of one (1) to three (3) medications at time of screening exam