A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

New World Medical, Inc.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intraocular Pressure Open Angle Glaucoma

Interventions

ab interno canaloplastyDEVICE

A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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. .

Locations (1)

Dr. Gabriel S. Lazcano Gomez

Puerto México, Mexico

Outcomes

Primary Outcomes

Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%

Descriptive

Time frame: From Baseline at Month 12

Secondary Outcomes

Changes from baseline in intraocular pressure (IOP)

Exploratory analysis

Time frame: From Baseline at Month 12

Changes from baseline in number of IOP lowering medications

Exploratory analysis

Time frame: From Baseline at Month 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.