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

Glaukos

Status and phase: Unknown; Phase 4

Conditions: Open-Angle Glaucoma

Treatments: Device: Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326079

GCF-005

Details and patient eligibility

About

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.

Full description

The study compares 1 stent versus 2 stents.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

1

Active Comparator group

Treatment:

Device: Stent

2

Active Comparator group

Treatment:

Device: Stent