Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT04700189
  4. Details
NCT04700189 Clinical Trial

A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM

Open Angle Glaucoma Clinical Trial

Official title:
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04700189
Other study ID # DF6-CL-20-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2020
Est. completion date September 21, 2022

Study information
Verified date May 2023
Source New World Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.

Description:

This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINE™ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date September 21, 2022
Est. primary completion date September 21, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: Subjects must meet all the following criteria in order to be eligible for participation in this study: 1. Subjects qualifying for cataract surgery 2. Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg. Exclusion Criteria: - Subjects are ineligible for participation in this study if s/he meets any of the following criteria: 1. Patients who could not be washed-out of IOP-lowering medications. .

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ab interno canaloplasty
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.

Locations
Country Name City State
Mexico Dr. Gabriel S. Lazcano Gomez Puerto Mexico

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

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of =20% Descriptive From Baseline at Month 12
Secondary Changes from baseline in intraocular pressure (IOP) Exploratory analysis From Baseline at Month 12
Secondary Changes from baseline in number of IOP lowering medications Exploratory analysis From Baseline at Month 12
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
Completed NCT01937312 - Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue Phase 4
Terminated NCT01983579 - TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection 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