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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive glaucoma surgery (MIGS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with serious device-related adverse event in study eye | 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. | 5 years post-implantation |
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Inclusion Criteria:
Exclusion Criteria:
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patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Oftalmologica del Caribe | Barranquilla | Colombia | ||||
| Center Hospotalier Universitaire Genoble Alpes |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Grenoble |
| 38043 |
| France |
| Hopital de la Croix-Rousse | Lyon | 69417 | France |
| Uniklinik Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Maxivision Eye Hospital | Hyderabad | Telangana | 500034 | India |
| Panama Eye Center | Panama City | Panama |
| Hospital Clínico San Carlos | Madrid | Spain |