iStent Inject New Enrollment Post-Approval Study

• Sponsor: Glaukos Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04624698
• Collaborator: (none)
• Enrollment: 358
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 67.3
• Patients Per Site: 119.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Sep 22, 2020
• Anticipated Primary Completion Date: May 1, 2026
• Anticipated Study Completion Date: May 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. iStent inject placement and stability [36 Months]

   The rate of clinically relevant complications associated with iStent inject placement and stability

Secondary Outcome Measures

1. Sight-threatening adverse events [36 Months]

   Rate of occurrence of sight-threatening adverse events

Other Outcome Measures

1. Other adverse events [36 Months]

   Rate of other adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Doctors of Arizona, PLLC	Phoenix	Arizona	United States	85003
2	Wolstan and Goldberg Eye Associates	Torrance	California	United States	90505
3	Glaucoma Associates of Texas	Dallas	Texas	United States	75231

Sponsors and Collaborators

• Glaukos Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glaukos Corporation
• ClinicalTrials.gov Identifier: NCT04624698
• Other Study ID Numbers: IG2M-105-PASN
• First Posted: Nov 12, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 31, 2022