PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
This study is gathering information on the PRESERFLO™ MicroShunt XI, a small device used to help manage a common eye condition called primary open-angle glaucoma. This condition causes pressure to build up inside the eye, which can damage vision if not controlled. The MicroShunt XI is designed to reduce this eye pressure by creating a tiny drainage path for fluid. The study will track how safe and effective the device is in patients who haven't had their eye pressure properly controlled by medications, or when their glaucoma is getting worse and surgery is needed. This is an observational study, meaning researchers will follow patients and collect data without comparing them to a different treatment group.
At a glance
What is this study about?
This study is about a medical device called the PRESERFLO™ MicroShunt XI, which is used for people with a common eye condition called primary open-angle glaucoma. Glaucoma happens when the pressure inside your eye becomes too high. This high pressure can gradually damage the nerve that connects your eye to your brain, potentially leading to vision loss if not treated. Often, eye drops or other medications can help lower this pressure, but for some people, these treatments aren't enough.
The PRESERFLO™ MicroShunt XI is a tiny tube designed to help reduce this eye pressure. It works by creating a new, very small drainage channel for the fluid that naturally circulates inside your eye. This fluid, called aqueous humour, can then flow from the front part of your eye, where the pressure is high, to a small 'bleb' (a tiny blister-like area) just under the surface of your eye, where the pressure is lower. This helps to bring the overall eye pressure down.
This study is tracking how well this device works and if it's safe for patients in the real world, after it has already been approved for use in the UK (it has a 'CE Mark'). It's an 'observational' study, which means doctors will simply follow patients who receive the device as part of their standard care and record information about their progress. There isn't a comparison group in this study, and no special tests beyond what a patient would normally have for their condition are being done. The aim is to gather more safety and performance information about the device.
Key takeaways
- This study evaluates a device (PRESERFLO™ MicroShunt XI) for primary open-angle glaucoma.
- The device aims to lower eye pressure when other treatments are insufficient.
- It's an observational study, tracking patient progress after receiving the device.
- Participation involves receiving the device and standard follow-up appointments.
- The goal is to gather more information on the device's safety and how well it works.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you would typically be an adult between 18 and 85 years old who has primary open-angle glaucoma. This means your eye pressure isn't well controlled with eye drops or other medications, and it's currently between 18 mmHg and 35 mmHg. Also, your glaucoma might be getting worse, suggesting that surgery is the next step. You must also be willing to follow the study's requirements and sign a consent form showing you understand and agree to take part.
There are several reasons why you might not be able to join the study. For example, if you have other types of glaucoma like angle-closure, neovascular, or uveitic glaucoma, or if you have had certain previous eye surgeries involving the surface of your eye. You would also be excluded if you have active eye infections, inflammation, or certain other eye conditions like vitreous in the anterior chamber, intraocular silicone oil, or an artificial lens in the front part of your eye. If you need other eye surgeries at the same time as the glaucoma procedure, or if your eye's clear front window (cornea) is unusually thick or thin, you might not be eligible. Also, if you're currently in another study or have been in one recently, you might not be able to participate.
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 between 18 and 85 years old?
- Do you have primary open-angle glaucoma that isn't well controlled with medication?
- Is your eye pressure currently between 18 mmHg and 35 mmHg?
- Do you need glaucoma surgery because your pressure is too high or your condition is getting worse?
- Have you not had certain previous eye surgeries or have active eye infections/inflammation?
What does participation involve?
If you decide to take part in this study, you would receive the PRESERFLO™ MicroShunt XI device as part of your glaucoma treatment. There would be regular follow-up visits with your eye doctor to monitor your eye pressure, check how well the device is working, and ensure your eye is healing properly. These visits would be similar to the care you would normally receive after glaucoma surgery. You won't be asked to change your medications beyond what your doctor thinks is best for your condition. The total duration of your involvement in the study would depend on how long your doctor needs to monitor your progress with the device, but it would involve several follow-up appointments over time.
Potential risks and benefits
Locations (11)
- AKH WienVerified postcodeVienna, Austria· Not yet recruiting
- Glaucoma Clinic, UZ LeuvenVerified postcodeLeuven, Belgium· Not yet recruiting
- Internationale Innovative Opthalmochirurgie GbRVerified postcodeDüsseldorf, Germany· Not yet recruiting
- Universitätsklinikum Tübingen, Department für AugenheilkundeVerified postcodeTübingen, Germany· Not yet recruiting
- Irccs Fondazione G. B. BiettiVerified postcodeRome, Italy· Not yet recruiting
- Policlinico Universitario MolinetteVerified postcodeTurin, Italy· Not yet recruiting
- Universiteitskliniek voor Oogheelkunde MaastrichtVerified postcodeMaastricht, Netherlands· Not yet recruiting
- ULS Santa Maria, LisboaVerified postcodeLisbon, Portugal· Not yet recruiting
- Hospital Clinico San CarlosVerified postcodeSan Carlos, Spain· Not yet recruiting
- Guy's and St. Thomas' NHS Foundation TrustVerified postcodeLondon, United Kingdom· Recruiting
- Moorfields Eye Hospital NHS Foundation TrustVerified postcodeLondon, United Kingdom· Not yet recruiting
Common questions
What is primary open-angle glaucoma?
It's a common eye condition where pressure inside the eye gradually builds up, which can damage the nerve connecting your eye to your brain and lead to vision loss if not treated.
What is the PRESERFLO™ MicroShunt XI?
It's a small, tube-like device designed to create a drainage path for fluid inside the eye, helping to lower eye pressure when medications haven't been enough.
Will I have to take different medicines for this study?
No, your doctor will continue to manage your eye medications as they normally would to ensure the best care for your glaucoma.
Is this a new treatment?
The PRESERFLO™ MicroShunt XI has already been approved for use in the UK, but this study aims to gather more information on its safety and effectiveness in real-world patients.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point without it affecting your ongoing medical care.
How to find out more
Study Director / Medical Monitor Raymund Angeles
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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