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Active not recruitingOBSERVATIONAL

STAR-LIFE: a Post-market Registry on MINIject

This study, called STAR-LIFE, is looking at a new, tiny device called MINIject. This device is used to treat a common eye condition known as open-angle glaucoma. The main purpose of the study is to collect information about how MINIject is used in everyday life, outside of strict research settings. Researchers want to know how easy it is to use, how patients feel about their experience and their vision after getting the implant, and to make sure it's safe over two years following the surgery. This helps ensure that the MINIject continues to be a good option for people with glaucoma. It's a 'post-market' study, meaning the device is already available, and this research helps gather more experiences from a wider group of people.

At a glance

Status
Active not recruiting
Sponsor
iSTAR Medical
Enrolment target
320
Start
20 Jul 2022
Estimated completion
01 Dec 2028

What is this study about?

This study, called STAR-LIFE, is designed to gather more information about a small device known as MINIject. This tiny implant is used to help people who have a common eye condition called open-angle glaucoma. Glaucoma can damage the nerve that connects your eye to your brain, and if left untreated, it can lead to vision loss. The MINIject is already approved for use, but this study is a way for doctors and researchers to keep track of how it performs in many different patients in their regular clinics, not just in strict research settings.

The main goals of this study are to understand three key things. Firstly, how easy and practical the MINIject device is for doctors to use. Secondly, and perhaps most importantly for patients, it will collect feedback directly from people who have received the implant about how they are doing and what their vision is like. This is called 'patient-reported outcomes'. Finally, the study will carefully monitor the safety of the device over a two-year period after the surgery. By collecting all this information, we can build a better picture of how well MINIject works for people in their daily lives.

This kind of study is important because it helps ensure that treatments like MINIject continue to be good and safe options for patients over the long term. It collects 'real-world data', which means information from a wide range of patients receiving the treatment as part of their standard care. This adds to what we already know from earlier research and helps improve understanding for future patients.

Key takeaways

  • This study looks at a tiny implant for open-angle glaucoma called MINIject.
  • It gathers information on how MINIject works and its safety in real-life use over two years.
  • Participation means sharing information from your regular medical appointments, not extra visits.
  • Your feedback on your vision and experience is important for the study.
  • This research helps doctors understand the MINIject device better for future patients.
  • You can always choose to stop being part of the study at any time.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. You must have been diagnosed with a type of eye condition called open-angle glaucoma, and either have already had the MINIject implant or be planning to have it. It’s also very important that you are able to understand the study and agree to take part freely.

There are some reasons why you wouldn't be able to join. For example, if you have other types of glaucoma, such as ‘angle-closure glaucoma’, or glaucoma caused by an injury, inflammation, or another illness, you won't be eligible. Also, if you have known allergies to silicone, as the MINIject contains this material, you wouldn't be able to take part. Finally, if for any reason you are unable to understand and give your consent to join, you wouldn't be included.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with open-angle glaucoma?
  3. Have you had the MINIject implant, or are you planning to get one?
  4. Do you understand what the study involves and feel able to give your permission to take part?
  5. Do you have any allergies to silicone?
  6. Do you have any other types of glaucoma, like angle-closure glaucoma or glaucoma caused by injury or another illness?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't have any extra visits to the hospital or clinic beyond your usual follow-up appointments after your MINIject surgery. The researchers will simply collect information from your routine medical records during these regular check-ups. You won't be asked to take any new medicines or have any additional tests specifically for the study. The information will be collected for up to two years after you've had your MINIject implant. Your doctor will explain exactly what data they will be recording from your regular care.

Potential risks and benefits

The main benefit of taking part is that the information collected about your experience will help improve understanding of the MINIject device for other patients in the future. Since this study uses information from your standard care, there are no additional risks beyond those of your routine glaucoma treatment and MINIject surgery. You will not have any extra procedures or medicines. Remember, you can decide to stop taking part in the study at any time, for any reason, without it affecting your medical care.

Locations (15)

  • Medizinische Universität Graz
    Verified postcode
    Graz, Austria
  • Universitätsklinik für Augenheilkunde u. Optometrie
    Verified postcode
    Salzburg, Austria
  • Universitätsklinik für Augenheilkunde und Optometrie
    Verified postcode
    Vienna, Austria
  • Knappschaftskrankenhaus University Hospital
    Verified postcode
    Bochum, Germany
  • International Innovative Ophtalmochirurgie GbR,
    Verified postcode
    Düsseldorf, Germany
  • Asklepios Klinik Nord - Heidberg Klinik für Augenheilkunde
    Verified postcode
    Hamburg, Germany
  • Augenzentrum ONE/Nordblick Augenklinik Bellevue
    Verified postcode
    Kiel, Germany
  • Universitatsklinikum Schleswig-Holstein Klinik für Augneheilkunde
    Verified postcode
    Lübeck, Germany
  • Universitätsklinikum Ulm / Augenklinik
    Verified postcode
    Ulm, Germany
  • Glaucoma Research Center, Swiss Visio, Montchoisi clinic
    Verified postcode
    Lausanne, Switzerland
  • East Suffolk and North Essex NHS foundation trust
    Verified postcode
    Colchester, United Kingdom
  • Princess Alexandra Eye Pavilion, NHS Lothian
    Verified postcode
    Edinburgh, United Kingdom

Common questions

What is open-angle glaucoma?

It's a common eye condition where pressure inside your eye slowly builds up, which can damage the nerve connecting your eye to your brain and potentially lead to vision loss if not treated.

What is MINIject?

It's a tiny implant that is placed in your eye during surgery to help reduce the pressure inside your eye, treating open-angle glaucoma.

Will I have more hospital visits if I join?

No, you won't have any extra visits beyond your normal check-ups after your MINIject surgery. The study simply collects information from these routine appointments.

Does this study involve new medicines?

No, you won't be given any new medicines for this study. It's about collecting information on how the MINIject device works in real life.

Can I leave the study if I change my mind?

Yes, you can decide to stop taking part at any time without it affecting your ongoing medical care.

How to find out more

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

Discussion

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