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.
Study Type
OBSERVATIONAL
Enrollment
300
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.
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
RECRUITINGCenter Hospotalier Universitaire Genoble Alpes
Grenoble, France
ACTIVE_NOT_RECRUITINGHopital de la Croix-Rousse
Lyon, France
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.
Time frame: 5 years post-implantation
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Uniklinik Köln
Cologne, North Rhine-Westphalia, Germany
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Mainz
Mainz, Rhineland-Palatinate, Germany
ACTIVE_NOT_RECRUITINGKlinikum der Universität München
München, Germany
RECRUITINGMaxivision Eye Hospital
Hyderabad, Telangana, India
RECRUITINGPanama Eye Center
Panama City, Panama
ACTIVE_NOT_RECRUITINGHospital Clínico San Carlos
Madrid, Spain
ACTIVE_NOT_RECRUITING