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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:
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
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: 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:
Cataract
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Lens Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014