Status:
COMPLETED
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
Lead Sponsor:
New World Medical, Inc.
Conditions:
Intraocular Pressure
Open Angle Glaucoma
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamline™ Surgical System.
Detailed 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 glauc...
Eligibility Criteria
Inclusion
- Subjects must meet all the following criteria in order to be eligible for participation in this study:
- Subjects qualifying for cataract surgery
- Subjects with diagnosis of open-angle glaucoma in at least one eye with unmedicated IOP of 21-36 mmHg.
Exclusion
- Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
- Patients who could not be washed-out of IOP-lowering medications. .
Key Trial Info
Start Date :
December 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04700189
Start Date
December 4 2020
End Date
September 21 2022
Last Update
May 11 2023
Active Locations (1)
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1
Dr. Gabriel S. Lazcano Gomez
Puerto México, Mexico, 72190