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A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323284
First Posted: May 9, 2006
Last Update Posted: April 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Glaukos Corporation
  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 open-angle glaucoma or ocular hypertension and co-existing cataract.

Condition Intervention Phase
Open-Angle Glaucoma Device: iStent plus Cataract Surgery Procedure: Cataract surgery only Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

Resource links provided by NLM:


Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:
  • Intraocular Pressure (Measured in mm Hg) Less or Equal to 21 mm Hg on no Topical Hypotensive Meds [ Time Frame: 12 months ]
    Subjects with an intraocular pressure (IOP) less than or equal to 21 mm Hg without use of topical hypotensive medication at 12 months


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 months ]
    Subjects with an intraocular pressure (IOP) reduction from baseline of greater than or equal to 20% without use of topical hypotensive medication at 12 months


Enrollment: 240
Study Start Date: June 2005
Study Completion Date: March 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A--iStent plus Cataract Surgery
iStent plus Cataract Surgery
Device: iStent plus Cataract Surgery
ab interno trabecular bypass stent surgery
Other Name: iStent Surgery
Active Comparator: B--Cataract Surgery Only
Cataract Surgery only
Procedure: Cataract surgery only
Cataract surgery only
Other Name: Phacoemulsification

Detailed Description:
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 open-angle glaucoma or ocular hypertension and co-existing cataract. Pre-operative unmedicated baseline pressures will be compared with post operative values in both study arms.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma (OAG) in the study eye. Pseudoexfoliative and pigmentary glaucoma are also acceptable diagnoses.
  • Subject on at least one glaucoma medication
  • Able and willing to attend follow up visits for two years post operative
  • Able and willing to sign informed consent

Exclusion Criteria:

  • Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)
  • Angle closure glaucoma
  • Fellow eye already enrolled
  Contacts and Locations
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): NCT00323284


  Show 31 Study Locations
Sponsors and Collaborators
Glaukos Corporation
Investigators
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
  More Information

Publications:
Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT00323284     History of Changes
Other Study ID Numbers: GC-003
First Submitted: May 6, 2006
First Posted: May 9, 2006
Results First Submitted: September 4, 2012
Results First Posted: October 4, 2012
Last Update Posted: April 26, 2016
Last Verified: March 2016

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery

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