iStent Inject New Enrollment Post-Approval Study

Glaukos

Status: Active, not recruiting

Conditions: Glaucoma; Glaucoma, Open-Angle

Treatments: Device: iStent Inject Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04624698

IG2M-105-PASN

Details and patient eligibility

About

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

Full 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.

Enrollment: 358 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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358 participants in 1 patient group

Implantation

Experimental group

Description:

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

Treatment:

Device: iStent Inject Implantation