A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

Not Applicable

Completed

• Conditions: Intraocular Pressure; Open Angle Glaucoma
• Interventions: Device: ab interno canaloplasty

• Registration Number: NCT04700189
• Lead Sponsor: New World Medical, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2020-12-04
• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2022-09-21
• Study Completion: 2022-09-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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. .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with Streamline following cataract surgery	ab interno canaloplasty	Treatment with Streamline System following phacoemulsification

Primary Outcome Measures

Name	Time	Method
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%	From Baseline at Month 12	Descriptive

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in number of IOP lowering medications	From Baseline at Month 12	Exploratory analysis
Changes from baseline in intraocular pressure (IOP)	From Baseline at Month 12	Exploratory analysis

Trial Locations

Locations (1)

Dr. Gabriel S. Lazcano Gomez; 🇲🇽 Puerto Mexico, Mexico