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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New World Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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