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OpenTrials
Completed

NCT Number: NCT04700189

A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

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

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Key information

Conditions

Intraocular Pressure Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Open Angle Glaucoma

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Gabriel S. Lazcano Gomez

Puerto México, 72190, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all the following criteria in order to be eligible for participation in this study:

  • Subjects qualifying for cataract surgery
  • 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:
  • Patients who could not be washed-out of IOP-lowering medications. .

Treatment and study plan

ab interno canaloplasty

Device

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

Primary outcomes

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

    Time frame: From Baseline at Month 12

    Descriptive

Secondary outcomes

  1. Changes from baseline in intraocular pressure (IOP)

    Time frame: From Baseline at Month 12

    Exploratory analysis

  2. Changes from baseline in number of IOP lowering medications

    Time frame: From Baseline at Month 12

    Exploratory analysis

Sponsors and collaborators

Lead sponsor

New World Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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