A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

New World Medical

Status: Completed

Conditions: Open Angle Glaucoma; Intraocular Pressure

Treatments: Device: ab interno canaloplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT04700189

DF6-CL-20-03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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. .

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Treatment with Streamline following cataract surgery

Experimental group

Description:

Treatment with Streamline System following phacoemulsification

Treatment:

Device: ab interno canaloplasty