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NCT05280366 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

— VENICE  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05280366
Other study ID # DF6-CL-21-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 9, 2022
Est. completion date June 30, 2026

Study information
Verified date April 2024
Source New World Medical, Inc.
Contact Elysia Ison, OD
Phone 408-348-7408
Email eison@newworldmedical.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study of the Streamline Surgical System versus competitor

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Streamline Surgical System
Completion of the Streamline Surgical System procedure
• iStent Inject W
Implantation of competitor device

Locations
Country Name City State
Costa Rica Clinica 20/20 San José
United States Georgia Eye Partners Atlanta Georgia
United States University of Colorado Aurora Colorado
United States Eye Associates of North New Jersey Dover New Jersey
United States Vold Vision Fayetteville Arkansas
United States Ophthalmology Associates Fort Worth Texas
United States The Eye Institute Louisville Kentucky
United States Piedmont Eye Center Lynchburg Virginia
United States University Eye Specialists Maryville Tennessee
United States Visionary Research Institute Newport Beach California
United States Ocala Eye Ocala Florida
United States Ross Eye Institute Orchard Park New York
United States Eye Centers of Racine and Kenosha Racine Wisconsin
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Ophthalmology Associates Saint Louis Missouri
United States R & R Eye Research San Antonio Texas
United States Wolstan and Goldberg Eye Associates Torrance California
United States Eye Associates Surgical Center Vineland New Jersey

Sponsors (1)
Lead Sponsor Collaborator
New World Medical, Inc.

Countries where clinical trial is conducted

United States,  Costa Rica, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in mean unmedicated diurnal Intraocular Pressure (IOP) Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time 24 months
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