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Clinical Trials/NCT00326014
NCT00326014
Completed
Phase 4

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

Glaukos Corporation8 sites in 3 countries58 target enrollmentApril 2003

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Open-Angle Glaucoma
Sponsor
Glaukos Corporation
Enrollment
58
Locations
8
Primary Endpoint
Efficacy
Status
Completed
Last Updated
10 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
December 2009
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy

Time Frame: 24 months

Study Sites (8)

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