Trials / Completed
CompletedNCT04700189
A FIH Trial of the STREAMLINE™ SURGICAL SYSTEM
A First in Human Clinical Trial to Evaluate the Safety and Effectiveness of the STREAMLINE™ SURGICAL SYSTEM in Patients With Open-Angle Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- New World Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ab interno canaloplasty | A modification of traditional canaloplasty procedure. Can be combined with or done without cataract surgery. |
Timeline
- Start date
- 2020-12-04
- Primary completion
- 2022-09-21
- Completion
- 2022-09-21
- First posted
- 2021-01-07
- Last updated
- 2023-05-11
Locations
1 site across 1 country: Mexico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04700189. Inclusion in this directory is not an endorsement.