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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04624698
Other study ID # IG2M-105-PASN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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