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

Phase 4

Completed

• Conditions: Open-Angle Glaucoma

• Registration Number: NCT00326014
• Lead Sponsor: Glaukos Corporation

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-16
• Primary Completion: 2008-03
• Study Completion: 2009-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy	24 months

Trial Locations

Locations (8)

Klinik Vincentinum; 🇩🇪 Augsburg, Germany

Universitats Augenklinik; 🇩🇪 Freiburg, Germany

Rotkreuz Krankenhaus; 🇩🇪 München, Germany

Klinikum Neubrandenburg; 🇩🇪 Neubrandenburg, Germany

Augenaerztliche Gemeinschaftspraxis; 🇩🇪 Weinheim, Germany

Clinico San Carlos; 🇪🇸 Madrid, Spain

Instituto Oftalmológico de Aragón; 🇪🇸 Zaragoza, Spain

Augenklinik Kantonsspital; 🇨🇭 Winterthur, Switzerland