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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
History of Changes

May 6, 2006
September 4, 2012
June 2005
July 2009   (final data collection date for primary outcome measure)
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
  • Efficacy
  • The primary effectiveness measure will be intraocular pressure reduction from preoperative un medicated baseline in the test group as compared to intraocular pressure reduction observed in the concurrent control group.
  • Safety
  • Comparison on the incidence of all adverse events that occur during the intraoperative and postoperative period in both study arms.
Complete list of historical versions of study NCT00323284 on ClinicalTrials.gov Archive Site
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
To evaluate glaucoma medications preoperatively vs postoperatively.
Not Provided
Not Provided
 
A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Open Angle Glaucoma
A Study of the Glaukos Trabecular Micro-Bypass Stent in Combination With Cataract Surgery in Open Angle Glaucoma Subjects.

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Open-Angle Glaucoma
  • Device: iStent plus Cataract Surgery
    ab interno trabecular bypass stent surgery
    Other Name: iStent Surgery
  • Procedure: Cataract surgery only
    Cataract surgery only
    Other Name: Phacoemulsification
  • Active Comparator: A--iStent plus Cataract Surgery
    iStent plus Cataract Surgery
    Intervention: Device: iStent plus Cataract Surgery
  • Active Comparator: B--Cataract Surgery Only
    Cataract Surgery only
    Intervention: Procedure: Cataract surgery only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
March 2010
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00323284
GC-003
No
Glaukos Corporation
Glaukos Corporation
Not Provided
Study Director: Jeff Wells, PharmD, MBA Glaukos Corporation
Glaukos Corporation
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP