A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

Glaukos Corporation61 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma.

The study compares 1 stent versus 2 stents.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-Angle Glaucoma

Interventions

StentDEVICE

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with open-angle glaucoma (OAG) * Subject on at least one glaucoma medication * Signed informed consent Exclusion Criteria: * Angle closure glaucoma * Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma * Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc) * Fellow eye already enrolled

Locations (7)

Vienna Medical University

Vienna, Austria

Klinik Vincentinum

Augsburg, Germany

Mainz University

Mainz, Germany

Private Practice

Weinheim, Germany

Outcomes

Primary Outcomes

Efficacy

Time frame: 24 months

Data from ClinicalTrials.gov

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