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Clinical Trials/NCT00326040
NCT00326040CompletedPhase 4

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

Glaukos Corporation7 sites in 4 countries45 target enrollmentStarted: April 1, 2003Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
45
Locations
7
Primary Endpoint
Efficacy
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 refractory open-angle glaucoma subjects.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

A

Experimental

Intervention: Glaucoma Surgery (Device)

Outcomes

Primary Outcomes

Efficacy

Time Frame: 24 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry

Study Sites (7)

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