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

NCT05280366 | Active Not Recruiting FDA Device

• 1 other identifier: DF6-CL-21-02
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 20

Brief Summary

A study of the Streamline Surgical System versus competitor

Conditions

Open Angle Glaucoma

Keywords

glaucoma; Goniotomy; MIGS

Outcome Measures

Primary Outcomes (1)

• Change in mean unmedicated diurnal Intraocular Pressure (IOP)

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

  24 months

Study Arms (2)

Streamline Surgical System

OTHER

Streamline Surgical System procedure administered

Device: Streamline Surgical System

iStent Inject W

ACTIVE COMPARATOR

iStent Inject W implanted

Device: iStent Inject W

Interventions

Streamline Surgical System DEVICE

Completion of the Streamline Surgical System procedure

Streamline Surgical System

iStent Inject W DEVICE

Implantation of competitor device

iStent Inject W

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Mild to Moderate Primary Open Angle Glaucomma

You may not qualify if:

• 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.

Sponsors & Collaborators

• New World Medical, Inc.: lead

Study Sites (20)

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Visionary Research Institute

Newport Beach, California, 92663, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Ocala Eye

Ocala, Florida, 34474, United States

Location

Georgia Eye Partners

Atlanta, Georgia, 30342, United States

Location

The Eye Institute

Louisville, Kentucky, 40206, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Eye Associates of North New Jersey

Dover, New Jersey, 07927, United States

Location

Eye Associates Surgical Center

Vineland, New Jersey, 08361, United States

Location

Ross Eye Institute

Orchard Park, New York, 14127, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

University Eye Specialists

Maryville, Tennessee, 37003, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Berkely Eye Center

Houston, Texas, 77027, United States

Location

R & R Eye Research

San Antonio, Texas, 78229, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24052, United States

Location

Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

Clinica 20/20

San José, 10108, Costa Rica

Location

Clinica Laser y Ultrasonido Ocular

Puebla City, 72530, Mexico

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Elysia Ison, OD

  New World Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 15, 2022
• Study Start: February 9, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); CO (1); ME (1)