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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Glaukos Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00326066
First received: May 12, 2006
Last updated: March 28, 2013
Last verified: March 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 
Study First Received: May 12, 2006
Last Updated: March 28, 2013
Health Authority: Spain: Spanish Agency of Medicines

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

ClinicalTrials.gov processed this record on December 08, 2016