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

Glaukos

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma

Treatments: Device: iStent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326014

GC-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

A

Experimental group

Treatment:

Device: iStent