iStent Inject New Enrollment Post-Approval Study

iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma; Glaucoma, Open-Angle
• Intervention / Treatment: Device: iStent Inject Implantation

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.

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85003
      • Eye Doctors of Arizona, PLLC
  • California
    • Torrance, California, United States, 90505
      • Wolstan and Goldberg Eye Associates
  • Texas
    • Dallas, Texas, United States, 75231
      • Glaucoma Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iStent inject placement and stability	The rate of clinically relevant complications associated with iStent inject placement and stability	36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sight-threatening adverse events	Rate of occurrence of sight-threatening adverse events	36 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other adverse events	Rate of other adverse events	36 Months

Collaborators and Investigators

• Sponsor: Glaukos Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

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): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: IG2M-105-PASN

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• 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