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The purpose of this study is to evaluate the safety and Intraocular pressure lowering effectiveness of the Streamlineâ„¢ Surgical System.
This is a prospective, nonrandomized, open-label study evaluating the safety and IOP-lowering effectiveness of CPI Visco-Surgical System (STREAMLINEâ„¢ SURGICAL SYSTEM) in patients with open-angle glaucoma undergoing cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with Streamline following cataract surgery | Experimental | Treatment with Streamline System following phacoemulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ab interno canaloplasty | Device | A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of unmedicated eyes with intraocular pressure (IOP) reduction of ≥20% | Descriptive | From Baseline at Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in intraocular pressure (IOP) | Exploratory analysis | From Baseline at Month 12 |
| Changes from baseline in number of IOP lowering medications | Exploratory analysis |
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Inclusion Criteria:
Subjects must meet all the following criteria in order to be eligible for participation in this study:
Exclusion Criteria:
Subjects are ineligible for participation in this study if s/he meets any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Lozcano, MD | Puebla, Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Gabriel S. Lazcano Gomez | Puerto México | 72190 | Mexico |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 21, 2025 | |
| Reset | May 6, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2025 | May 6, 2025 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| From Baseline at Month 12 |