Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
Open Angle Glaucoma, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Ocular hypertension
Brief 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.
Interventions
DEVICEMinimally 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.
Sponsors
iSTAR Medical
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patient who received a MINIject glaucoma implant within a prior clinical study * Patient continues to have MINIject implanted at the point of enrolment * Patient must provide written informed consent to participate
Exclusion criteria
* Individuals under tutorship or trusteeship * Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with serious device-related adverse event in study eye | 5 years post-implantation | The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation. |
Countries
Colombia, France, Germany, India, Panama, Spain
Outcome results
None listed