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

Sponsored by:	Glaukos Corporation
Information provided by:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT00326066

Purpose

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.

Condition	Intervention	Phase
Open-Angle Glaucoma	Device: Glaucoma Surgery Procedure: cataract surgery only	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma High Blood Pressure Surgery

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

Efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	47
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Active Comparator	Device: Glaucoma Surgery 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.
2: Placebo Comparator	Procedure: cataract surgery only Subjects will undergo routine cataract surgery only (no stent implant).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326066

Locations

Austria
Vienna Medical Hospital
Vienna, Austria, A-1090
Germany
Universitats- Augenklinik
Wurzburg, Germany, D-97080
Mainz University
Mainz, Germany
Augenklinik der Technischen Universitat
Munich, Germany, 81675
Netherlands
Ophthalmic Clinic
Rotterdam, Netherlands
The Netherlands Ophthalmic Research Institute
Amsterdam, Netherlands
Spain
Clinico San Carlos
Madrid, Spain, 28040
Instituto Oftalmológico de Aragón
Zaragoza, Spain, 50007
Turkey
Beyoglu Eye Research and Education Hospital
Istanbul, Turkey

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Director:

Head of Clinical Affairs

Glaukos Corporation

More Information

No publications provided

Responsible Party:	Glaukos Corporation ( Head of Clinical Affairs )
Study ID Numbers:	GCF-007
Study First Received:	May 12, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00326066 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Glaukos Corporation:

Open angle
Glaucoma
Surgery
Cataract

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract
Glaucoma, Open-Angle

Lens Diseases
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Cataract

Glaucoma, Open-Angle
Lens Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on September 01, 2009