iStent Inject New Enrollment Post-Approval Study

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04624698
• Other study ID #: IG2M-105-PASN
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: May 2026

Study information

• Verified date: February 2024
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 358
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Device:
• iStent Inject Implantation
Subjects will be implanted with the iStent Injection Micro-Bypass device

Locations

Country	Name	City	State
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Eye Doctors of Arizona, PLLC	Phoenix	Arizona
United States	Wolstan and Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other adverse events	Rate of other adverse events	36 Months
Primary	iStent inject placement and stability	The rate of clinically relevant complications associated with iStent inject placement and stability	36 Months
Secondary	Sight-threatening adverse events	Rate of occurrence of sight-threatening adverse events	36 Months