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NCT00326040 Clinical Trial

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

Open-Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00326040
Other study ID # GC-001A
Secondary ID
Status Completed
Phase Phase 4
First received May 12, 2006
Last updated July 23, 2008
Start date April 2003
Est. completion date August 2007

Study information
Verified date July 2008
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Glaucoma Surgery

Locations
Country Name City State
Germany University of Cologne Cologne
Germany Klinik für Augenheilkunde Neubradenbrug
Italy University Eye Clinic Genova
Italy Instituto di Oftalmologia Parma
Netherlands Ophthalmic Clinic Rotterdam
Spain Hospital Clínico San Carlos Madrid
Spain Instituo Oftalmologico de Aragon Zaragoza

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy 24 months No
See also
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