A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

NCT ID: NCT04700189

Last Updated: 2023-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-04

Study Completion Date

2022-09-21

Brief Summary

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

Detailed Description

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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.

Conditions

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Intraocular Pressure Open Angle Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Streamline following cataract surgery

Treatment with Streamline System following phacoemulsification

Group Type EXPERIMENTAL

ab interno canaloplasty

Intervention Type DEVICE

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

Interventions

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ab interno canaloplasty

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

Intervention Type DEVICE

Eligibility Criteria

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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. .
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New World Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel Lozcano, MD

Role: PRINCIPAL_INVESTIGATOR

Puebla, Mexico

Locations

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Dr. Gabriel S. Lazcano Gomez

Puerto México, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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DF6-CL-20-03

Identifier Type: -

Identifier Source: org_study_id

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