RecruitingOBSERVATIONAL

Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device

This study is looking at a new eye surgery machine called the Virtuoso DUAL Advanced Vision Solutions system. It's designed to help doctors perform two common types of eye operations: removing cataracts (cloudy lenses) and a procedure called a vitrectomy. During a vitrectomy, doctors remove a jelly-like substance from inside the eye, often to fix problems like retinal detachment. This study isn't yet approved for sale, so doctors are carefully testing it to make sure it's safe and works as expected. They'll also be gathering opinions from the surgeons who use it. If you're having one of these eye operations, you might be asked to take part. The goal is to make sure this new device is a good and safe option for eye surgery.

At a glance

Status

Recruiting

Sponsor

Beaver-Visitec International, Inc.

Enrolment target

205

Start

03 Dec 2025

Estimated completion

01 Nov 2026

Cataract Vitrectomy Vitrectomy Operation Under General Anesthesia

What is this study about?

This study is about a new piece of equipment for eye surgery called the Virtuoso DUAL Advanced Vision Solutions system. This system is designed to help eye surgeons perform two main types of operations: removing cataracts and a procedure called a vitrectomy. Cataracts are when the natural lens of your eye becomes cloudy, making your vision blurry. A vitrectomy is an operation where the surgeon removes the jelly-like substance from the middle of your eye, often to treat problems with the retina, which is the light-sensitive layer at the back of your eye.

This new system isn't widely available yet, so this study is an important step to make sure it's safe and works well. Doctors will be using it during routine eye operations on people who agree to take part. They'll be carefully watching how the device works, whether the surgery can be completed successfully, and if there are any unexpected problems. They're also keen to get feedback from the surgeons who use it.

The main aim is to confirm that the Virtuoso system is a safe and effective tool for eye surgeons to use. By taking part, you would be helping us learn more about this new technology, which could improve eye surgery for many people in the future. All participants will receive the standard of care for their eye condition.

Key takeaways

This study is testing a new device for cataract and vitrectomy eye surgeries.
It aims to ensure the device is safe and works well for patients.
You must be 18 or older and need one of these eye operations to join.
Your safety and recovery will be closely monitored after surgery.
Participation helps improve eye surgery for future patients.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and already scheduled for a vitrectomy (an operation removing the jelly from your eye), a cataract operation, or both. It's really important that you're willing to sign a consent form, showing you understand what the study involves and agree to take part. You also need to be able to attend all the planned check-up appointments.

However, there are some reasons why you might not be able to join. For example, if you're under 18, or if you won't be able to come for a follow-up appointment about 3 months after your operation. You also can't take part if you've already had a specific type of eye surgery called scleral buckling, or if you have certain other eye conditions like severe glaucoma or a history of eye inflammation.

Other reasons you might not be able to join include having untreated diabetes, certain problems with the size of your eye, or if you're pregnant or breastfeeding. If you've recently taken part in another eye-related study (within the last 30 days), you would also not be able to join this one.

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 18 years old or older?
Are you scheduled for a cataract removal or vitrectomy eye operation?
Can you attend follow-up appointments for about 3 months after your surgery?
Are you NOT pregnant or breastfeeding?
Do you NOT have severe eye conditions like advanced glaucoma or certain corneal problems?
Have you NOT recently taken part in another eye study (in the last 30 days)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will undergo your planned eye surgery (either for cataracts, a vitrectomy, or both) using the new Virtuoso device. This means the surgeon will use this specific equipment instead of other tools they might normally use. After your operation, you'll need to attend scheduled follow-up visits, just like you would for any eye surgery. During these visits, doctors will check your eyes and gather information about how you're recovering and how the device performed.

There are no special medications involved in this study. The total duration of your participation will include your surgery and then follow-up appointments, which will typically last until about 3 months after your operation. Throughout this time, the study team will be checking on your progress to ensure the device is safe and effective.

Potential risks and benefits

Taking part in this study means you'll undergo your planned eye surgery with a new device being tested. Potential benefits include contributing to medical knowledge that could improve eye surgery for others. The risks are generally similar to those of any standard eye surgery, as the device is being used for its intended purpose. However, with any new device, there's always a small chance of unforeseen issues. You will be closely monitored, and your safety is the top priority. Remember, you can choose to leave the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Ludwig Maximilian University of Munich
Verified postcode
Munich, Germany· Recruiting

Common questions

What is a cataract?

A cataract is when the natural lens in your eye becomes cloudy, making your vision blurry. It's a very common eye condition, especially as people get older.

What is a vitrectomy?

A vitrectomy is an eye operation where a surgeon removes the clear, jelly-like substance from the middle of your eye. This is often done to fix problems with the retina at the back of your eye.

Is the Virtuoso system safe?

This study is specifically designed to confirm the safety and how well the Virtuoso system works. It's being very carefully monitored by doctors and researchers.

Will I get special treatment if I join?

No, you will receive the same high standard of care for your eye condition as any other patient. The main difference is the specific equipment used during your operation.

What if I change my mind about taking part?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare team.

How to find out more

Siegfried Priglinger, Dr. med.

siegfried.priglinger@med.uni-muenchen.de +49 (0)89 4400 53811 Official trial record

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