MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
This study is for people who have both primary open-angle glaucoma and cataracts. It's testing a new, tiny eye implant called MINIject, which is designed to help lower the pressure inside the eye for those whose glaucoma isn't controlled by eye drops. The study will combine placing this implant with standard cataract surgery. Researchers want to see how safe the MINIject implant is and how well it works to reduce eye pressure over a period of two years. If you're considering cataract surgery and also have glaucoma that's hard to manage with medication, this trial might be relevant to you. The main goal is to find out if this combined approach can be a good treatment option.
At a glance
What is this study about?
This research study is looking at a new way to help people who have two common eye conditions at once: primary open-angle glaucoma and cataracts. Glaucoma is a condition where the pressure inside your eye becomes too high, which can damage your optic nerve and lead to vision loss if not treated. Cataracts are when the lens of your eye becomes cloudy, making your vision blurry. Many people need surgery to replace their cloudy lens with a clear one.
In this study, doctors are investigating whether a tiny device called MINIject can be safely and effectively implanted into the eye at the same time as cataract surgery. The MINIject is a type of 'minimally invasive glaucoma surgery' (MIGS), meaning it's a smaller procedure than traditional glaucoma operations. It's designed to create a new path for fluid to drain from the eye, helping to reduce that dangerous high pressure. This study is खास for people whose eye pressure hasn't been brought down enough by eye drops alone.
The main aim is to see if combining the MINIject implant with cataract surgery is a good way to lower eye pressure over the long term, and to make sure it's safe. Doctors will first perform cataract surgery. If that goes well, they will then place the MINIject implant. The study will carefully follow participants for two years to check their eye pressure, vision, and overall eye health.
Key takeaways
- Tests a new implant (MINIject) for glaucoma.
- Combines implant with cataract surgery.
- Aims to lower eye pressure for uncontrolled glaucoma.
- Involves regular check-ups for two years.
- For individuals with both glaucoma and cataracts.
Who may be eligible?
To be part of this study, you would need to have both primary open-angle glaucoma in the eye being treated and a cataract that needs surgery. It's important that your glaucoma hasn't been controlled well enough by eye drops, unless you can't use those drops due to allergies or other reasons.
You also need to be able to fully understand and agree to take part in the study yourself. You wouldn't be able to join if you have known allergies to certain medical materials like silicone, or if you have specific other eye conditions like silicone oil already in your eye. The study is open to both men and women, generally aged 40 and over.
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.
- Do I have primary open-angle glaucoma in one eye?
- Do I have a cataract in the same eye that needs surgery?
- Are my current glaucoma eye drops not enough to control my eye pressure (or can't I use them)?
- Am I generally healthy enough for eye surgery?
- Am I able to understand and sign consent forms myself?
- Am I not allergic to silicone or certain other medications?
What does participation involve?
If you decide to take part, the first step would be to have your cataract surgery. If this is successful, the MINIject implant would then be placed during the same procedure. After your surgery, you would need to attend regular follow-up appointments over a period of two years. During these visits, the doctors will perform standard eye tests to check your eye pressure, examine the back of your eye, take pictures of your eye, and look for any changes or problems. This is to make sure the implant is working well and that you are recovering properly. You can expect to have several visits over these two years to monitor your eye health.
Potential risks and benefits
Locations (4)
- Panama Eye CenterVerified postcodePanama City, Panama
- Hospital Clínico San CarlosVerified postcodeMadrid, Spain
- East Suffolk and North Essex NHS Foundation Trust - Colchester General HospitalVerified postcodeColchester, United Kingdom
- Princess Alexandra Eye PavilionVerified postcodeEdinburgh, United Kingdom
Common questions
What is primary open-angle glaucoma?
It's a common eye condition where the pressure inside your eye slowly builds up, which can harm the nerve that connects your eye to your brain, potentially leading to vision loss.
What is a cataract?
A cataract is when the natural lens inside your eye becomes cloudy, making your vision blurry, hazy, or less colourful. It's often treated with surgery.
What is the MINIject implant?
It's a tiny medical device that is placed in your eye during surgery. Its job is to help fluid drain better from your eye to lower the pressure caused by glaucoma.
How long will I be in the study?
You will be carefully watched and have check-ups for two years after your surgery.
Can I still take my eye drops for glaucoma?
This study is for people whose glaucoma isn't well controlled by eye drops alone. Your doctor will discuss your medications with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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