RecruitingOBSERVATIONAL

MINIject Global Long-Term Follow-up Study

This study is a long-term follow-up for people who have received a small implant called MINIject, used to treat glaucoma. Glaucoma is an eye condition where pressure inside the eye can damage the optic nerve. The MINIject implant is designed to help lower this pressure. Participants in this study have already had the MINIject implant for two years as part of an earlier trial. This new study aims to check how safe and well the implant works over a longer period, up to five years in total. Researchers will monitor eye health, including eye pressure, through regular check-ups. The goal is to gather important information about the implant's benefits and any potential issues over many years.

At a glance

Status

Recruiting

Sponsor

iSTAR Medical

Enrolment target

300

Start

05 Aug 2020

Estimated completion

01 Dec 2025

Open Angle Glaucoma Ocular Hypertension

What is this study about?

This research study is about checking how well a small device called MINIject works in the long run for people with glaucoma. Glaucoma is an eye condition that can damage your eyesight, often because the pressure inside your eye is too high, even if it doesn't always cause pain. The MINIject implant is a tiny device carefully placed in the eye to help reduce this pressure, especially for people whose glaucoma isn't well controlled by eye drops alone.

For this particular study, we're inviting people who have already had the MINIject implant for two years as part of a previous research study. We want to see how the implant performs over a much longer time, specifically up to five years after it was first put in. This long-term information is really important because it helps doctors understand the benefits and any potential side effects of the MINIject over many years, not just a short period.

Every year, participants will have their eyes checked by an eye specialist. These check-ups will help us confirm that the implant is still working as it should and that it remains safe. It involves standard eye tests you might already be familiar with, such as measuring eye pressure, looking at the back of your eye, and taking pictures of your eye. Collecting this information helps us to keep improving treatments for glaucoma.

Key takeaways

This study tracks the long-term safety and performance of the MINIject implant for glaucoma.
It's for people who have already had the MINIject device for two years in a previous study.
You'll have yearly eye check-ups for up to three more years.
The goal is to understand how the implant works over five years.
Participation involves routine eye tests, not new treatments.

Who may be eligible?

This study is specifically looking for people who have already had a MINIject implant as part of an earlier research study. You would need to still have the implant in your eye when you join this long-term follow-up study.

To be considered, you must be willing to give your written permission to take part. This means signing a form that explains the study in detail and shows you understand what's involved.

Unfortunately, if you are not willing to attend the yearly appointments or have the necessary eye tests, this study wouldn't be right for you. Also, people who are under the formal care of a guardian or trustee would not be able to participate. This study is open to both men and women between the ages of 18 and 99.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have already had a MINIject implant as part of an earlier research study.
The MINIject implant is still in my eye.
I am aged between 18 and 99 years old.
I'm happy to attend yearly eye appointments for up to three more years.
I can provide written permission to join the study.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be invited to continue your yearly check-ups at the hospital or clinic. These appointments will happen once a year for up to three more years, adding to the two years you've already been followed, for a total of up to five years since your implant. Each visit will involve standard eye tests to check your vision, eye pressure, and the overall health of your eye, including looking at the back of your eye and potentially taking some photos. There are no new medications involved in this follow-up study, only the ongoing monitoring of your eye with the existing MINIject implant. The total duration of your involvement in this follow-up study will be up to three years.

Potential risks and benefits

Participating in this study might offer the benefit of continued close monitoring of your eye health and the MINIject implant by specialists, potentially identifying any issues early. As you've already had the implant for two years, major risks from the implant itself are less likely to emerge now, but all medical procedures carry some potential for long-term complications, which will be monitored. The main risk involved in participating would be the time commitment for yearly visits and the minor discomfort associated with eye examinations. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Clinica Oftalmologica del Caribe
Verified postcode
Barranquilla, Colombia· Recruiting
Center Hospotalier Universitaire Genoble Alpes
Verified postcode
Grenoble, France· Active not recruiting
Hopital de la Croix-Rousse
Verified postcode
Lyon, France· Active not recruiting
Uniklinik Köln
Verified postcode
Cologne, Germany· Active not recruiting
Universitätsklinikum Mainz
Verified postcode
Mainz, Germany· Active not recruiting
Klinikum der Universität München
Verified postcode
München, Germany· Recruiting
Maxivision Eye Hospital
Verified postcode
Hyderabad, India· Recruiting
Panama Eye Center
Verified postcode
Panama City, Panama· Active not recruiting
Hospital Clínico San Carlos
Verified postcode
Madrid, Spain· Active not recruiting

Common questions

What is Open Angle Glaucoma?

It's the most common type of glaucoma where drainage canals in your eye become less efficient, causing pressure to build up and potentially damage the optic nerve.

What is the MINIject implant for?

The MINIject is a tiny device placed in the eye to help lower the eye pressure for people with glaucoma, often when eye drops alone aren't enough.

Why is this study only for people who've already had the implant?

This study is a follow-up to an earlier trial. It helps researchers understand how the MINIject implant works over many years, after it's already shown to be safe initially.

How long will I be in this study?

You'll be followed for up to three more years, adding to the two years you've already been monitored, for a total of up to five years since your implant surgery.

Will I have new treatments or medications in this study?

No, this study is only about observing how your MINIject implant performs over the long term. There are no new treatments or medications given as part of this follow-up.

How to find out more

Esma Islamaj, PhD

esma.islamaj@istarmed.com +32 10 77 12 52 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.