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

Glaukos Corporation47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Open-Angle Glaucoma

Interventions

Glaucoma SurgeryDEVICE

Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.

cataract surgery onlyPROCEDURE

Subjects will undergo routine cataract surgery only (no stent implant).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Vienna Medical Hospital

Vienna, Austria

Mainz University

Mainz, Germany

Augenklinik der Technischen Universitat

Munich, Germany

Universitats- Augenklinik

Würzburg, Germany

Outcomes

Primary Outcomes

Efficacy

Time frame: 24 months

Data from ClinicalTrials.gov

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