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OpenTrials
Completed

NCT Number: NCT00326014

A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik Vincentinum, Augsburg, Germany

Loading trial locations.

About this study

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

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 at least one glaucoma medication
  • Patient requiring cataract surgery and an intraocular lens implantation

Exclusion criteria

  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Angle closure glaucoma

Treatment and study plan

iStent

Device

Glaucoma Surgery

Other names: Glaukos iStent

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 Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Important dates

Study start
2003
Primary completion
2008
Study completion
2009
First posted
May 16, 2006
Registry last updated
Jun 8, 2015

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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