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Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

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: NCT01461278
Recruitment Status : Active, not recruiting
First Posted : October 28, 2011
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Tracking Information
First Submitted Date  ICMJE October 25, 2011
First Posted Date  ICMJE October 28, 2011
Last Update Posted Date April 30, 2021
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
≥ 20% Reduction in IOP [ Time Frame: Baseline to Month 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2011)
Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
Diurnal IOP Reduction from Baseline [ Time Frame: Baseline to Month 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
Official Title  ICMJE A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
Brief Summary Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Detailed Description This is an IDE trial to evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Primary Open-angle Glaucoma
Intervention  ICMJE
  • Device: iStent supra
    Cataract surgery and implantation of one iStent supra
  • Procedure: Cataract surgery
    Cataract surgery alone
Study Arms  ICMJE
  • Experimental: Cataract surgery plus iStent supra
    Interventions:
    • Device: iStent supra
    • Procedure: Cataract surgery
  • Active Comparator: Cataract surgery
    Intervention: Procedure: Cataract surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2015)
1200
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
200
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild to moderate open-angle glaucoma
  • Characteristics consistent with mild to moderate glaucoma
  • Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

  • Pigmentary or pseudoexfoliative glaucoma
  • Prior incisional glaucoma surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01461278
Other Study ID Numbers  ICMJE GC-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glaukos Corporation
Study Sponsor  ICMJE Glaukos Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kerry Stephens, O.D. Glaukos Corporation
PRS Account Glaukos Corporation
Verification Date April 2021

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