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

A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension

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.

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.

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