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NCT04700189 Clinical Trial

A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04700189
Other study ID # DF6-CL-20-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2020
Est. completion date September 21, 2022

Study information
Verified date May 2023
Source New World Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• ab interno canaloplasty
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.

Locations
Country Name City State
Mexico Dr. Gabriel S. Lazcano Gomez Puerto Mexico

Sponsors (1)
Lead Sponsor Collaborator
New World Medical, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of =20% Descriptive From Baseline at Month 12
Secondary Changes from baseline in intraocular pressure (IOP) Exploratory analysis From Baseline at Month 12
Secondary Changes from baseline in number of IOP lowering medications Exploratory analysis From Baseline at Month 12
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