Status:

UNKNOWN

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

Lead Sponsor:

Glaukos Corporation

Conditions:

Open-Angle Glaucoma

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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.

Detailed Description

The study compares 1 stent versus 2 stents.

Eligibility Criteria

Inclusion

  • Diagnosed with open-angle glaucoma (OAG)
  • Subject on at least one glaucoma medication
  • Signed informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2013

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT00326079

Start Date

August 1 2004

End Date

May 1 2013

Last Update

March 29 2013

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Vienna Medical University

Vienna, Austria, A-1090

2

Klinik Vincentinum

Augsburg, Germany, 86150

3

Mainz University

Mainz, Germany

4

Private Practice

Weinheim, Germany, D-69469