Trials / Active Not Recruiting
Active Not RecruitingNCT05024695
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 975 (estimated)
- Sponsor
- iSTAR Medical · Industry
- Sex
- All
- Age
- 46 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
Detailed description
This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MINIject™ Implant | The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space. |
Timeline
- Start date
- 2021-08-19
- Primary completion
- 2027-07-01
- Completion
- 2029-07-01
- First posted
- 2021-08-27
- Last updated
- 2025-09-12
Locations
37 sites across 4 countries: United States, Canada, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05024695. Inclusion in this directory is not an endorsement.