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

NCT ID: NCT05280366

Last Updated: 2024-11-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study of the Streamline Surgical System versus competitor

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Streamline Surgical System

Streamline Surgical System procedure administered

Group Type OTHER

Streamline Surgical System

Intervention Type DEVICE

Completion of the Streamline Surgical System procedure

iStent Inject W

iStent Inject W implanted

Group Type ACTIVE_COMPARATOR

iStent Inject W

Intervention Type DEVICE

Implantation of competitor device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Streamline Surgical System

Completion of the Streamline Surgical System procedure

Intervention Type DEVICE

iStent Inject W

Implantation of competitor device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New World Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elysia Ison, OD

Role: STUDY_DIRECTOR

New World Medical, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vold Vision

Fayetteville, Arkansas, United States

Site Status

Visionary Research Institute

Newport Beach, California, United States

Site Status

Wolstan and Goldberg Eye Associates

Torrance, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Ocala Eye

Ocala, Florida, United States

Site Status

Georgia Eye Partners

Atlanta, Georgia, United States

Site Status

The Eye Institute

Louisville, Kentucky, United States

Site Status

Ophthalmology Associates

St Louis, Missouri, United States

Site Status

Eye Associates of North New Jersey

Dover, New Jersey, United States

Site Status

Eye Associates Surgical Center

Vineland, New Jersey, United States

Site Status

Ross Eye Institute

Orchard Park, New York, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

University Eye Specialists

Maryville, Tennessee, United States

Site Status

Ophthalmology Associates

Fort Worth, Texas, United States

Site Status

Berkely Eye Center

Houston, Texas, United States

Site Status

R & R Eye Research

San Antonio, Texas, United States

Site Status

Piedmont Eye Center

Lynchburg, Virginia, United States

Site Status

Eye Centers of Racine and Kenosha

Racine, Wisconsin, United States

Site Status

Clinica 20/20

San José, , Costa Rica

Site Status

Clinica Laser y Ultrasonido Ocular

Puebla City, , Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Costa Rica Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DF6-CL-21-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.