CClinicalTrials.gg
Status unknownNCT04624685Updated Oct 20, 2021

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

An observational study in Glaucoma, Open-Angle, sponsored by Glaukos Corporation. Status unknown at 24 sites in United States. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Glaukos Corporation · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
475
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Glaucoma, Open-Angle

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03

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's planned enrollment of 475 is above the median of 101 across 182 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
475 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. iStent inject Placement and Stability

    Rate of clinically relevant complications associated with iStent inject placement and stability.

    Time frame: 60 Months

Secondary outcomes

  1. Sight-Threatening Adverse Events

    Rate of occurrence of sight-threatening adverse events

    Time frame: 60 Months

Other outcomes

  1. Secondary Surgical Interventions

    Rate of Secondary Surgical Interventions

    Time frame: 60 Months

  2. Adverse Events

    Rate of other adverse Events

    Time frame: 60 Months

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Study locations

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

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04624685
Lead sponsor
Glaukos Corporation
Responsible party
Sponsor
First posted
Nov 12, 2020
Start date
Jan 15, 2020
Primary completion
Jan 20, 2021
Completion
Dec 2021 (estimated)
Last update
Oct 20, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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