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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00326079

Enrollment

Registered

2006-05-16

Start date

2004-08-31

Completion date

2013-05-31

Last updated

2013-03-29

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, 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 subjects with open-angle glaucoma.

Detailed description

The study compares 1 stent versus 2 stents.

Interventions

DEVICEStent

implantation of 1 Glaukos iStent versus 2 Glaukos iStents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy	24 months

Countries

Austria, Germany, Spain, Turkey (Türkiye)

Outcome results

None listed

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