Trials / Recruiting
RecruitingNCT04524416
MINIject Global Long-Term Follow-up Study
A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- iSTAR Medical · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The study will assess the long-term (up to 5 years) 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 aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Minimally invasive glaucoma surgery (MIGS) | MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study. |
Timeline
- Start date
- 2020-08-05
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2020-08-24
- Last updated
- 2025-02-28
Locations
9 sites across 6 countries: Colombia, France, Germany, India, Panama, Spain
Source: ClinicalTrials.gov record NCT04524416. Inclusion in this directory is not an endorsement.