MINIject Global Long-Term Follow-up Study (STAR-GLOBAL)

iSTAR Medical

Status: Enrolling

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Device: Minimally invasive glaucoma surgery (MIGS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04524416

STAR-GLOBAL (ISM09)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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