iStent Inject New Enrollment Post-Approval Study

Not Applicable

Active, not recruiting

• Conditions: Glaucoma; Glaucoma, Open-Angle
• Interventions: Device: iStent Inject Implantation

• Registration Number: NCT04624698
• Lead Sponsor: Glaukos Corporation

Brief Summary

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

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 Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2020-11-05
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 358

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Implantation	iStent Inject Implantation	Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device.

Primary Outcome Measures

Name	Time	Method
iStent inject placement and stability	36 Months	The rate of clinically relevant complications associated with iStent inject placement and stability

Secondary Outcome Measures

Name	Time	Method
Sight-threatening adverse events	36 Months	Rate of occurrence of sight-threatening adverse events

Trial Locations

Locations (3)

Eye Doctors of Arizona, PLLC; 🇺🇸 Phoenix, Arizona, United States

Wolstan and Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States