A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

May 9, 2023 updated by: New World Medical, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puerto Mexico, Mexico, 72190
        • Dr. Gabriel S. Lazcano Gomez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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. .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with Streamline following cataract surgery
Treatment with Streamline System following phacoemulsification
Device: ab interno canaloplasty
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
Time Frame: From Baseline at Month 12
Descriptive
From Baseline at Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in intraocular pressure (IOP)
Time Frame: From Baseline at Month 12
Exploratory analysis
From Baseline at Month 12
Changes from baseline in number of IOP lowering medications
Time Frame: From Baseline at Month 12
Exploratory analysis
From Baseline at Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New World Medical, Inc.

Investigators

  • Principal Investigator: Gabriel Lozcano, MD, Puebla, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2020

Primary Completion (Actual)

September 21, 2022

Study Completion (Actual)

September 21, 2022

Study Registration Dates

First Submitted

December 18, 2020

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF6-CL-20-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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