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Completed

NCT Number: NCT00326040

A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

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 refractory open-angle glaucoma subjects.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Cologne, Cologne, Germany

Loading trial locations.

About this study

Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with primary open-angle glaucoma (POAG)
  • Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
  • Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion criteria

  • Angle closure glaucoma
  • Fellow eye already enrolled

Treatment and study plan

Glaucoma surgery

Device

Primary outcomes

  1. Efficacy

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

Important dates

Study start
2003
Study completion
2007
First posted
May 16, 2006
Registry last updated
Jul 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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