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NCT00326079 Clinical Trial

A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2

Open-Angle Glaucoma Clinical Trial

Official title:
A Study of the Glaukos Trabecular Micro-bypass Stent in Open Angle Glaucoma Subjects 1 Stent Versus 2 Stents

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00326079
Other study ID # GCF-005
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received May 12, 2006
Last updated March 28, 2013
Start date August 2004
Est. completion date May 2013

Study information
Verified date March 2013
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
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 subjects with open-angle glaucoma.

Description:

The study compares 1 stent versus 2 stents.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 61
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with open-angle glaucoma (OAG)

- Subject on at least one glaucoma medication

- Signed informed consent

Exclusion Criteria:

- Angle closure glaucoma

- Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma

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

- Fellow eye already enrolled

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Stent
implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Locations
Country Name City State
Austria Vienna Medical University Vienna
Germany Klinik Vincentinum Augsburg
Germany Mainz University Mainz
Germany Private Practice Weinheim
Spain Hospital Clínico San Carlos Madrid
Spain Instituto Oftalmológico de Aragón Zaragoza
Turkey Beyoglu Eye Research and Education Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Countries where clinical trial is conducted

Austria,  Germany,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy 24 months No
See also
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Completed NCT01444040 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Phase 4
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