Not yet recruitingNAINTERVENTIONAL

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma

This study is investigating a new treatment for open-angle glaucoma called MINIject S+. Glaucoma is an eye condition that can damage your vision. The MINIject S+ is a tiny implant designed to help lower the pressure inside your eye. In the first part of the study, researchers are testing three different tools to find the safest and most effective way to insert the MINIject S+ device. Patients and the doctors checking the results won't know which tool is used. If a tool works well, it will be used in the second part of the study. This second part will involve more people who have glaucoma and also need cataract surgery, to see how well the device works alongside that operation.

At a glance

Status

Not yet recruiting

Phase

Sponsor

iSTAR Medical

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Mar 2028

Glaucoma

What is this study about?

This research is looking into a new treatment for a common eye condition called open-angle glaucoma. Glaucoma happens when the pressure inside your eye gets too high, which can damage the nerve that connects your eye to your brain and potentially harm your eyesight over time. This new small device, called MINIject S+, is designed to help reduce this pressure.

The study has two main parts. In the first part, the researchers want to figure out the best way to put the MINIject S+ device into your eye. They will be trying out three different tools to insert the device. Neither you nor the doctors who are reviewing the results will know which tool is being used. This helps make sure the results are fair and unbiased. The goal here is to find the insertion tool that works the most safely and effectively.

Once they've chosen the best tool, the study moves to its second part. This part will involve more people with glaucoma, especially those who also need cataract surgery. Cataract surgery is a common operation to replace a cloudy lens in your eye with a clear one. This part of the study will check how well MINIject S+ works for a larger group of people when it's put in during the same operation as cataract surgery.

Key takeaways

This study is testing a new device (MINIject S+) for open-angle glaucoma.
It aims to find the best way to put the device into your eye.
The device helps lower eye pressure to protect your vision.
Some participants might have the device implanted during cataract surgery.
The study will check how safe and effective the MINIject S+ is.

Who may be eligible?

To be considered for this study, you would need to be at least 20 years old and have been diagnosed with open-angle glaucoma in the eye being studied. Your glaucoma should not be fully controlled by your current eye drops, unless you cannot use them due to allergies or other reasons. Your vision in the study eye also needs to be at a certain level, and slightly better in your other eye.

Your eye doctor will check the angle inside your eye (where fluid drains) to make sure it's wide enough for the device. If you're in the second part of the study and also having cataract surgery, there are extra checks. These include making sure your cataract can be safely removed and that certain things look good inside your eye after the cataract surgery, before the MINIject S+ is put in.

There are also specific reasons why someone might not be able to join the study, which your doctor would discuss with you. Generally, you need to be willing to follow all study instructions and attend all scheduled appointments.

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.

Are you 20 years old or older?
Do you have open-angle glaucoma in at least one eye?
Are your glaucoma eye drops not fully controlling your eye pressure (or can you not use them)?
Are you able and willing to attend all study visits and follow instructions?
If you also need cataract surgery, is it suitable for an operation?

Answer every question to see your result.

What does participation involve?

Taking part would involve several visits to the clinic for examinations and checks. You would undergo an eye operation to have the MINIject S+ device implanted. If you are part of the second group in the study, this operation might happen at the same time as your cataract surgery. After the surgery, there will be follow-up appointments to monitor your eye pressure, check the device, and see how you are recovering. The study will last for a certain period, and you will be informed about the full duration and all required appointments before you agree to participate. You would also need to take any prescribed medications and follow all instructions from the study team.

Potential risks and benefits

Potential benefits of participating include receiving a new treatment for glaucoma that might help lower your eye pressure more effectively. However, as with any surgery, there are potential risks, such as infection, bleeding, or problems with the device. Your sight could also temporarily or permanently change. You will be fully informed about all possible risks and benefits before deciding to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Los Robles Vision d/b/a Centro Oftalmológico Robles
Verified postcode
Santa Rosa de Copán, Honduras
Colchester General Hospital
Verified postcode
Colchester, United Kingdom
St Thomas' Hospital
Verified postcode
London, United Kingdom

Common questions

What is open-angle glaucoma?

It's an eye condition where the pressure inside your eye gradually builds up. This can damage the nerve connecting your eye to your brain and affect your vision over time.

What is MINIject S+?

It's a tiny, new device that's put into your eye to help lower the pressure, which is important in treating glaucoma.

Will I know which insertion tool is used if I'm in Part 1?

No, both you and the doctors looking at the results won't know which tool was used. This is to make sure the study is fair.

Can I join if I also need cataract surgery?

Yes, if you're eligible for the second part of the study, the MINIject S+ could be implanted during your cataract surgery.

What if my current eye drops aren't working enough?

This study might be an option if your glaucoma isn't well-controlled with your current eye drops, or if you can't use them.

How to find out more

Florence Defresne, PhD

florence.defresne@istar-medical.com 003210771251 Official trial record

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