MINIject Global Long-Term Follow-up Study

N/AActive Not RecruitingNCT04524416

iSTAR Medical116 enrolled

Overview

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

116

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (9)

Clinica Oftalmologica del Caribe

Barranquilla, Colombia

Center Hospotalier Universitaire Genoble Alpes

Grenoble, France

Hopital de la Croix-Rousse

Lyon, France

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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