Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT05280366
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT03284853 - Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension Phase 3
Terminated NCT03611530 - CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma N/A
Not yet recruiting NCT06441643 - Next Generation Rocklatan Phase 2
Not yet recruiting NCT02868502 - Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02272569 - STARflo European Safety and Efficacy Study N/A
Completed NCT01936389 - A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma Phase 2
Completed NCT00941525 - Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure Phase 4
Completed NCT00539526 - Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues Phase 4
Completed NCT00121147 - Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan N/A
Active, not recruiting NCT05035394 - Swedish Microinvasive Glaucoma Surgery Study (SMIGS) N/A
Completed NCT03450629 - Evaluation of Safety and Efficacy of PDP-716 Phase 3
Active, not recruiting NCT06061718 - Travoprost Intraocular Implant in Conjunction With Cataract Surgery Phase 3
Recruiting NCT05241938 - PSLT Compared to Prostaglandin Analogue Eye Drops N/A
Completed NCT01342406 - Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
Completed NCT02250612 - SYL040012, Treatment for Open Angle Glaucoma Phase 2
Completed NCT01937299 - Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z® Phase 4
Terminated NCT01983579 - TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection Phase 4
Completed NCT01937312 - Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue Phase 4
Completed NCT01229982 - A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma Phase 2