Trials / Unknown
UnknownNCT04517786
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
A Prospective, Open, 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
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- iSTAR Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
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
- 2021-01-15
- Primary completion
- 2022-05-16
- Completion
- 2023-12-31
- First posted
- 2020-08-18
- Last updated
- 2023-05-03
Locations
2 sites across 2 countries: India, Panama
Source: ClinicalTrials.gov record NCT04517786. Inclusion in this directory is not an endorsement.