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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00326040

Enrollment

Registered

2006-05-16

Start date

2003-04-30

Completion date

2007-08-31

Last updated

2008-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma

Keywords

Open angle, Glaucoma, Refractory, Surgery

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.

Interventions

DEVICEGlaucoma Surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy	24 months

Countries

Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026