iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma, Open-Angle

Detailed Description

To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

• Study Type: Observational
• Enrollment (Anticipated): 475

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arizona Advanced Eye Research Institute
  • Arkansas
    • Fayetteville, Arkansas, United States, 72704
      • Vold Vision, PLLC
  • California
    • Santa Rosa, California, United States, 95401
      • North Bath Eye Associates, Inc.
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Eye Center of Northern Colorado, PC
  • Florida
    • Cape Coral, Florida, United States, 33904
      • Argus Research
    • Tampa, Florida, United States, 33603
      • International Research Center
    • Venice, Florida, United States, 34285
      • Center for Sight
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC.
  • Illinois
    • Chicago, Illinois, United States, 60619
      • Chicago Eye Specialists
    • Orland Park, Illinois, United States, 60467
      • Arbor Center for Eye Care
  • Kansas
    • Overland Park, Kansas, United States, 66213
      • Stiles Eyecare Excellence
  • Massachusetts
    • Lancaster, Massachusetts, United States, 01523
      • D'Ambrosio Eye Care
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Kresge Eye Institute / Wayne State University
  • Missouri
    • Independence, Missouri, United States, 64055
      • Discover Vision Centers
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Northern New Jersey Eye Institute
  • New York
    • Slingerlands, New York, United States, 12159
      • Glaucoma Consultants of the Capital Region
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma eye Surgeons, PLLC
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research
    • Fort Worth, Texas, United States, 76102
      • Ophthalmology Associates
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
    • San Antonio, Texas, United States, 78229
      • R and R Eye Resarch, LLC
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Vistar Eye Center
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The Eye Center of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 475 eyes of 475 subjects. This is based on the number of randomized subjects in the GC-008 study followed for 24 months.

Description

Inclusion Criteria:

• Randomized subject followed for 24 months in the GC-008 study
• Able to understand study requirements
• Willing to attend scheduled follow-up exams for 5 years post-operatively
• Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iStent inject Placement and Stability	Rate of clinically relevant complications associated with iStent inject placement and stability.	60 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sight-Threatening Adverse Events	Rate of occurrence of sight-threatening adverse events	60 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Surgical Interventions	Rate of Secondary Surgical Interventions	60 Months
Adverse Events	Rate of other adverse Events	60 Months

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): January 20, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: IG2M-104-CONT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO