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.

To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

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