Trials / Completed
CompletedNCT05089474
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
- 45 (actual)
- Sponsor
- New World Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.
Detailed description
A prospective, nonrandomized, open label study to evaluate the safety and IOP lowering effectiveness of the Streamline Surgical System, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. This is a 12 month study conducted outside the US. Approximately 60 subjects will be enrolled.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Streamline Surgical System | The Streamline System is a device that delivers viscoelastic into Schlemm's Canal. |
Timeline
- Start date
- 2021-03-08
- Primary completion
- 2023-04-20
- Completion
- 2023-04-20
- First posted
- 2021-10-22
- Last updated
- 2023-10-13
Locations
3 sites across 3 countries: Costa Rica, Dominican Republic, Mexico
Source: ClinicalTrials.gov record NCT05089474. Inclusion in this directory is not an endorsement.