A Study of the Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00326014

Enrollment

Registered

2006-05-16

Start date

2003-04-30

Completion date

2009-12-31

Last updated

2015-06-08

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, Cataract, Surgery

Brief summary

To evaluate the safety and efficacy of a new trabecular bypass that is implanted in conjunction with cataract surgery in open angle glaucoma subjects.

Detailed description

Glaukos Corporation conducted a clinical research study at multiple investigational sites within Europe (8)

Interventions

DEVICEiStent

Glaucoma Surgery

Study design

Allocation

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 at least one glaucoma medication * Patient requiring cataract surgery and an intraocular lens implantation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Efficacy	24 months

Countries

Germany, Spain, Switzerland

Outcome results

None listed

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