A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.

Inclusion Criteria:

Subjects must meet all the following criteria in order to be eligible for participation in this study:

1. Subjects qualifying for cataract surgery
2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.

Exclusion Criteria:

• Subjects are ineligible for participation in this study if s/he meets any of the following criteria:

  1. Patients who could not be washed-out of IOP-lowering medications. .