search
Back to results

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

Primary Purpose

Open Angle Glaucoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Streamline Surgical System
iStent Inject W
Sponsored by
New World Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, Goniotomy, MIGS

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vold VisionRecruiting
  • Wolstan and Goldberg Eye AssociatesRecruiting
  • University of ColoradoRecruiting
  • Ocala EyeRecruiting
  • Georgia Eye PartnersRecruiting
  • Ophthalmology AssociatesRecruiting
  • Eye Associates Surgical CenterRecruiting
  • Black Hills Regional Eye InstituteRecruiting
  • University Eye SpecialistsRecruiting
  • Ophthalmology AssociatesRecruiting
  • R & R Eye ResearchRecruiting
  • Eye Centers of Racine and KenoshaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Streamline Surgical System

iStent Inject W

Arm Description

Streamline Surgical System procedure administered

iStent Inject W implanted

Outcomes

Primary Outcome Measures

Change in mean unmedicated diurnal Intraocular Pressure (IOP)
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time

Secondary Outcome Measures

Full Information

First Posted
December 29, 2021
Last Updated
October 9, 2023
Sponsor
New World Medical, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05280366
Brief Title
STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New World Medical, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study of the Streamline Surgical System versus competitor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
glaucoma, Goniotomy, MIGS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Streamline Surgical System
Arm Type
Other
Arm Description
Streamline Surgical System procedure administered
Arm Title
iStent Inject W
Arm Type
Active Comparator
Arm Description
iStent Inject W implanted
Intervention Type
Device
Intervention Name(s)
Streamline Surgical System
Intervention Description
Completion of the Streamline Surgical System procedure
Intervention Type
Device
Intervention Name(s)
iStent Inject W
Intervention Description
Implantation of competitor device
Primary Outcome Measure Information:
Title
Change in mean unmedicated diurnal Intraocular Pressure (IOP)
Description
Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elysia Ison, OD
Phone
408-348-7408
Email
eison@newworldmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Reynolds, MS
Phone
8176881689
Email
hreynolds@newworldmedical.com
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deanne Griffin
Email
dgriffin@voldvision.com
First Name & Middle Initial & Last Name & Degree
Janna Barnes
Email
jbarnes@voldvision.com
First Name & Middle Initial & Last Name & Degree
Steven Vold, MD
Facility Name
Wolstan and Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Hernandez-Montes
Email
cynthia@wgeye.com
First Name & Middle Initial & Last Name & Degree
Damien Goldberg, MD
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
steve Cho
Email
steve.cho@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Leonard Seibold, MD
Facility Name
Ocala Eye
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Shirley
Email
kshirley@ocalaeye.com
First Name & Middle Initial & Last Name & Degree
Mohammed ElMallah, MD
Facility Name
Georgia Eye Partners
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Monroe
Email
kimberly.monroe@eyesouthpartners.com
First Name & Middle Initial & Last Name & Degree
Gagan Sawhney, MD
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Urbansky
Phone
314-966-3377
Email
danielleurbansky@eyecare-partners.com
First Name & Middle Initial & Last Name & Degree
Rnajan Malhotra, MD
Facility Name
Eye Associates Surgical Center
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08361
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janie Flores
Email
jflores@sjeyeassociates.com
First Name & Middle Initial & Last Name & Degree
Sydney Tyson, MD
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizza Teller
Email
lteller@bhrei.com
First Name & Middle Initial & Last Name & Degree
Adam Jorgensen, MD
Facility Name
University Eye Specialists
City
Maryville
State/Province
Tennessee
ZIP/Postal Code
37003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Rivera
Email
krivera@universityeye.com
First Name & Middle Initial & Last Name & Degree
Kenneth Olander, MD
First Name & Middle Initial & Last Name & Degree
Matthew Rouse, MD
Facility Name
Ophthalmology Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rosado
Phone
817-332-2020
Email
jrosado@oafw2020.com
First Name & Middle Initial & Last Name & Degree
Brian Flowers, MD
Facility Name
R & R Eye Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Hazen
Email
maggie@eye-assoc.com
First Name & Middle Initial & Last Name & Degree
William Flynn, MD
Facility Name
Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Lightfield
Email
plightfield@amazingeye.com
First Name & Middle Initial & Last Name & Degree
Paul Singh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs