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Trial record 1 of 1 for:    NCT04624698
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iStent Inject New Enrollment Post-Approval Study

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ClinicalTrials.gov Identifier: NCT04624698
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation

Brief Summary:
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Glaucoma Device: iStent Inject Implantation Not Applicable

Detailed Description:
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Implantation
Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.
Device: iStent Inject Implantation
Subjects will be implanted with the iStent Injection Micro-Bypass device




Primary Outcome Measures :
  1. iStent inject placement and stability [ Time Frame: 36 Months ]
    The rate of clinically relevant complications associated with iStent inject placement and stability


Secondary Outcome Measures :
  1. Sight-threatening adverse events [ Time Frame: 36 Months ]
    Rate of occurrence of sight-threatening adverse events


Other Outcome Measures:
  1. Other adverse events [ Time Frame: 36 Months ]
    Rate of other adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 22 years of age
  2. Mild to moderate primary open-angle glaucoma
  3. Scheduled to undergo cataract surgery
  4. Able and willing to attend scheduled follow-up exams for three years postoperatively
  5. Able and willing to provide written informed consent on the IRB approved Informed Consent Form

    Operative Inclusion Criterion:

  6. Successful, uncomplicated cataract surgery

Exclusion Criteria:

  1. Angle closure glaucoma
  2. Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle
  3. Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04624698


Contacts
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Contact: Jason Schmitt, O.D. 949-481-0401 jschmitt@glaukos.com
Contact: Kerry Stephens, O.D. kstephens@glaukos.com

Locations
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United States, Arizona
Eye Doctors of Arizona, PLLC Recruiting
Phoenix, Arizona, United States, 85003
Contact: Jason Schmitt, O.D.    949-481-0401    jschmitt@glaukos.com   
United States, California
Wolstan and Goldberg Eye Associates Recruiting
Torrance, California, United States, 90505
Contact: Jason Schmitt, O.D.    949-481-0401    jschmitt@glaukos.com   
United States, Texas
Glaucoma Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Jason Schmitt, O.D.    949-481-0401    jschmitt@glaukos.com   
Sponsors and Collaborators
Glaukos Corporation
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Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT04624698    
Other Study ID Numbers: IG2M-105-PASN
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases