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

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term follow-up data on patients who received a MINIject glaucoma implant — a tiny device placed inside the eye to help drain fluid and reduce eye pressure — in a previous clinical study. **You may be eligible if...** - You previously participated in a clinical study in which you received a MINIject glaucoma implant - The implant is still in place in your eye - You are willing and able to attend follow-up study visits **You may NOT be eligible if...** - Your MINIject implant has been removed - You are unable or unwilling to return for study assessments - You are under guardianship or trusteeship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.