Trials / Completed
CompletedNCT03996200
MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
A Prospective, Open, Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject (MINI SO627) in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- iSTAR Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.
Detailed description
The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery. The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MINIject CS627 implant | MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye. |
Timeline
- Start date
- 2019-07-23
- Primary completion
- 2020-02-14
- Completion
- 2022-02-10
- First posted
- 2019-06-24
- Last updated
- 2023-05-03
Locations
3 sites across 3 countries: Colombia, India, Panama
Source: ClinicalTrials.gov record NCT03996200. Inclusion in this directory is not an endorsement.