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:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT00323284
First received: May 6, 2006
Last updated: September 4, 2012
Last verified: September 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 6, 2006
Results First Received: September 4, 2012
Last Updated: September 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Glaukos Corporation:
Open angle
Glaucoma
Cataract
Surgery

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

ClinicalTrials.gov processed this record on April 15, 2014