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

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.
ClinicalTrials.gov Identifier: NCT00323284
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : October 4, 2012
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 open-angle glaucoma or ocular hypertension and co-existing cataract.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
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.
Study Start Date : June 2005
Primary Completion Date : July 2009
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria

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:

  • 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