Intraocular Pressure, Open Angle Glaucoma
Conditions
Keywords
Intraocular Pressure, Glaucoma, Glaucoma Surgery, Ab interno
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.
Interventions
DEVICEab interno canaloplasty
A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery.
Sponsors
New World Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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. .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% | From Baseline at Month 12 | Descriptive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in intraocular pressure (IOP) | From Baseline at Month 12 | Exploratory analysis |
| Changes from baseline in number of IOP lowering medications | From Baseline at Month 12 | Exploratory analysis |
Countries
Mexico
Outcome results
None listed