Back to resultsA FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
Primary Purpose
Intraocular Pressure, Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
ab interno canaloplasty
Sponsored by
About this trial
This is an interventional treatment trial for Intraocular Pressure focused on measuring Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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. .
Sites / Locations
- Dr. Gabriel S. Lazcano Gomez
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Streamline following cataract surgery
Arm Description
Treatment with Streamline System following phacoemulsification
Outcomes
Primary Outcome Measures
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
Descriptive
Secondary Outcome Measures
Changes from baseline in intraocular pressure (IOP)
Exploratory analysis
Changes from baseline in number of IOP lowering medications
Exploratory analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04700189
Brief Title
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
September 21, 2022 (Actual)
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
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 glaucoma undergoing cataract surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Pressure, Open Angle Glaucoma
Keywords
Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Streamline following cataract surgery
Arm Type
Experimental
Arm Description
Treatment with Streamline System following phacoemulsification
Intervention Type
Device
Intervention Name(s)
ab interno canaloplasty
Intervention Description
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.
Primary Outcome Measure Information:
Title
Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20%
Description
Descriptive
Time Frame
From Baseline at Month 12
Secondary Outcome Measure Information:
Title
Changes from baseline in intraocular pressure (IOP)
Description
Exploratory analysis
Time Frame
From Baseline at Month 12
Title
Changes from baseline in number of IOP lowering medications
Description
Exploratory analysis
Time Frame
From Baseline at Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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. .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Lozcano, MD
Organizational Affiliation
Puebla, Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Gabriel S. Lazcano Gomez
City
Puerto Mexico
ZIP/Postal Code
72190
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
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