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

Not Applicable

Completed

• Conditions: Open-Angle Glaucoma
• Interventions: Device: Glaucoma Surgery; Procedure: cataract surgery only

• Registration Number: NCT00326066
• Lead Sponsor: Glaukos Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-16
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Glaucoma Surgery	-
2	cataract surgery only	-

Primary Outcome Measures

Name	Time	Method
Efficacy	24 months

Trial Locations

Locations (9)

Augenklinik der Technischen Universitat; 🇩🇪 Munich, Germany

Vienna Medical Hospital; 🇦🇹 Vienna, Austria

The Netherlands Ophthalmic Research Institute; 🇳🇱 Amsterdam, Netherlands

Beyoglu Eye Research and Education Hospital; 🇹🇷 Istanbul, Turkey

Ophthalmic Clinic; 🇳🇱 Rotterdam, Netherlands

Mainz University; 🇩🇪 Mainz, Germany

Universitats- Augenklinik; 🇩🇪 Wurzburg, Germany

Clinico San Carlos; 🇪🇸 Madrid, Spain

Instituto Oftalmológico de Aragón; 🇪🇸 Zaragoza, Spain