A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.

Glaukos

Status: Completed

Conditions: Open-Angle Glaucoma

Treatments: Procedure: cataract surgery only; Device: Glaucoma Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326066

GCF-007

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 newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.

Full description

The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.
• All subjects must need cataract surgery.

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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47 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Device: Glaucoma Surgery

2

Placebo Comparator group

Treatment:

Procedure: cataract surgery only