Trials / Completed
CompletedNCT02177123
Post Market Study of the InnFocus MicroShunt
Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- InnFocus Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients
Detailed description
The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InnFocus MicroShunt implantation | Implantation will include the use of Mitomycin C applied with sponges. |
Timeline
- Start date
- 2014-04-04
- Primary completion
- 2017-11-27
- Completion
- 2017-11-27
- First posted
- 2014-06-27
- Last updated
- 2021-06-24
- Results posted
- 2021-05-28
Locations
6 sites across 4 countries: France, Netherlands, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02177123. Inclusion in this directory is not an endorsement.