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

Sponsor

iSTAR Medical

Enrollment

300 participants

Start Date

Aug 5, 2020

Study Type

OBSERVATIONAL

Conditions

Open Angle Glaucoma Ocular Hypertension

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria3

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 Criteria2

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

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.