STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma (VENICE)

June 26, 2024 updated by: New World Medical, Inc.

A Prospective, Randomized, Multi-center Evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma

A study of the Streamline Surgical System versus competitor

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

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 Contact

Study Contact Backup

Study Locations

  • Costa Rica
      • San José, Costa Rica, 10108
        • Active, not recruiting
        • Clinica 20/20
  • United States
    • Arkansas
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Visionary Research Institute
        • Contact:
          • Elise Palencia
        • Principal Investigator:
          • Ehsan Sadri, MD
      • Torrance, California, United States, 90505
        • Recruiting
        • Wolstan and Goldberg Eye Associates
        • Principal Investigator:
          • Damien Goldberg, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Leonard Seibold, MD
    • Florida
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Ocala Eye
        • Contact:
        • Principal Investigator:
          • Mohammed ElMallah, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Active, not recruiting
        • Georgia Eye Partners
    • Kentucky
      • Louisville, Kentucky, United States, 40206
    • Missouri
      • Saint Louis, Missouri, United States, 63131
    • New Jersey
      • Dover, New Jersey, United States, 07927
        • Recruiting
        • Eye Associates of North New Jersey
        • Contact:
        • Principal Investigator:
          • Eric Mann, MD
      • Vineland, New Jersey, United States, 08361
        • Active, not recruiting
        • Eye Associates Surgical Center
    • New York
      • Orchard Park, New York, United States, 14127
        • Recruiting
        • Ross Eye Institute
        • Contact:
        • Principal Investigator:
          • Sandra Sieminski, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Black Hills Regional Eye Institute
        • Contact:
        • Principal Investigator:
          • Adam Jorgensen, MD
    • Tennessee
      • Maryville, Tennessee, United States, 37003
        • Recruiting
        • University Eye Specialists
        • Contact:
        • Principal Investigator:
          • Kenneth Olander, MD
        • Sub-Investigator:
          • Matthew Rouse, MD
    • Texas
      • Fort Worth, Texas, United States, 76102
        • Recruiting
        • Ophthalmology Associates
        • Principal Investigator:
          • Brian Flowers, MD
        • Contact:
      • Houston, Texas, United States, 77027
        • Recruiting
        • Berkely Eye Center
        • Contact:
        • Principal Investigator:
          • Moran Micheletti, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • R & R Eye Research
        • Contact:
        • Principal Investigator:
          • William Flynn, MD
    • Virginia
      • Lynchburg, Virginia, United States, 24052
        • Recruiting
        • Piedmont Eye Center
        • Contact:
          • Carla Torrance
        • Principal Investigator:
          • James Paauw, MD
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • Recruiting
        • Eye Centers of Racine and Kenosha
        • Contact:
        • Principal Investigator:
          • Paul Singh, MD

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:

Diagnosis of Mild to Moderate Primary Open Angle Glaucomma

Exclusion Criteria:

  • Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Streamline Surgical System
Streamline Surgical System procedure administered
Device: Streamline Surgical System
Completion of the Streamline Surgical System procedure
Active Comparator: iStent Inject W
iStent Inject W implanted
Device: iStent Inject W
Implantation of competitor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean unmedicated diurnal Intraocular Pressure (IOP)
Time Frame: 24 months
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
24 months

Collaborators and Investigators

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

Sponsor

New World Medical, Inc.

Investigators

  • Study Director: Elysia Ison, OD, New World Medical, Inc.

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)

February 9, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF6-CL-21-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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