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

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ClinicalTrials.gov Identifier: NCT00326066
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Device: Glaucoma Surgery Procedure: cataract surgery only Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 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.
Other Name: two Glaukos iStent Trabecular Bypass Microstents
Placebo Comparator: 2 Procedure: cataract surgery only
Subjects will undergo routine cataract surgery only (no stent implant).
Other Name: Phacoemulsification



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326066


Locations
Austria
Vienna Medical Hospital
Vienna, Austria, A-1090
Germany
Mainz University
Mainz, Germany
Augenklinik der Technischen Universitat
Munich, Germany, 81675
Universitats- Augenklinik
Wurzburg, Germany, D-97080
Netherlands
The Netherlands Ophthalmic Research Institute
Amsterdam, Netherlands
Ophthalmic Clinic
Rotterdam, 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00326066     History of Changes
Other Study ID Numbers: GCF-007
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Surgery
Cataract

Additional relevant MeSH terms:
Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases