RecruitingNAINTERVENTIONAL

Microsurgical Robot-assisted Corneal Transplant

This study is exploring a new way to perform full corneal transplants (called keratoplasty) using a tiny robot. Corneal transplants are important operations for people with severe eye conditions that affect their vision, often when no other treatments have worked. The robot is designed to help surgeons with the very precise stitching required during the transplant, which is usually done by hand. This research will be the first time a robot like this is used for corneal transplants in humans. The main goal is to see if using the robot can make the operation as good as, or even better than, traditional surgery, potentially leading to improved vision for patients. Researchers will also look at the costs involved in using the robot.

At a glance

Status

Recruiting

Phase

Sponsor

CHU de Reims

Enrolment target

Start

06 Jun 2025

Estimated completion

01 Apr 2027

Corneal Dystrophy

What is this study about?

Imagine the front clear window of your eye, called the cornea, becoming cloudy or damaged. This can make it very hard to see. For some people with serious eye conditions, the best solution is a full corneal transplant. This is a delicate operation where a surgeon replaces the damaged cornea with a healthy one from a donor. This type of surgery has been around for over a hundred years, and the main steps haven't changed much.

Now, a new kind of robot, called the Symani® surgical system, has been developed specifically for very tiny and precise operations, known as microsurgery. This robot has tiny tools that can move even more precisely than a human hand, and a surgeon controls it with a joystick and foot pedals. While robots are already used in other types of surgery, this study is the first to investigate if this particular robot can help with the intricate stitching needed during a corneal transplant in humans. The researchers have already tested the robot on corneas that couldn't be used for transplant, showing that it *is* possible to do the stitching with the robot.

The main aim of this study is to see how well the robot performs these important stitches during a real corneal transplant. Good stitching is vital because it affects the shape of the new cornea, which in turn impacts how well a person can see afterwards. The hope is that robot-assisted surgery could lead to equally good or even better vision results compared to surgery done entirely by hand. The study will also compare the costs of using the robot versus traditional methods.

Key takeaways

This study explores using a robot for delicate stitching in corneal transplants.
It aims to see if robot assistance can improve surgical precision and patient vision.
The surgeon operates the robot; it's not autonomous.
This is the first time this robot is used for human corneal transplants.
Follow-up care will be similar to standard corneal transplant recovery.

Who may be eligible?

To be considered for this study, you need to be an adult (18 to 60 years old) and have been seen at Reims University Hospital’s eye clinic. You must also need a full corneal transplant because of a severe eye condition called corneal dystrophy, which significantly affects your vision.

It’s important that you are covered by a social security plan and are willing to understand and sign a consent form to participate. This ensures you know what the study involves before you agree to join.

There are also some reasons why you might not be able to join. For example, if you have other serious eye problems apart from your corneal dystrophy, or if you can't fully understand and follow the study instructions, you wouldn't be able to take part. Also, if you are legally unable to make your own decisions, you cannot 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 60 years old?
Do you need a full corneal transplant for corneal dystrophy?
Are you a patient at Reims University Hospital's eye clinic?
Do you have social security coverage?
Are you able to understand and sign consent forms?
Do you *not* have other serious eye conditions that aren't corneal dystrophy?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a full corneal transplant operation as you would normally, but some of the very fine stitching will be done using the special robot. This surgery will be carried out under general anaesthetic. You will receive eye drops for several years after the surgery to help your eye heal and prevent complications. Some stitches will be removed about 6 months to 1 year after your operation. The researchers will closely monitor your vision and recovery. This study focuses on your surgical procedure and your follow-up will be similar to standard care, with additional checks to see how the robot-assisted surgery compares. The total duration of your participation will be from the time you agree to join until your stitches are removed and your vision has stabilised, which could be up to a year or more.

Potential risks and benefits

The potential benefit of participating in this study is that robot-assisted surgery *might* lead to a more precise surgical outcome, which *could* ultimately improve your vision or recovery compared to traditional surgery. However, this is a new approach for human corneal transplants, so the exact benefits are still being investigated. As with any surgery, there are risks, including those associated with general anaesthesia, infection, bleeding, or problems with the new cornea. Your surgeon will discuss all potential risks with you in detail. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Chu Reims
Verified postcode
Reims, France· Recruiting

Common questions

What is a corneal transplant?

A corneal transplant (or keratoplasty) is an operation where a damaged cornea (the clear front part of the eye) is replaced with a healthy one from a donor to improve vision.

What is a 'robot-assisted' operation?

It means a surgeon uses a special robot with tiny, precise tools to help them perform very delicate parts of the operation, like stitching, often with greater accuracy than human hands alone.

Will the robot be doing the surgery all by itself?

No, the robot is a tool. The surgeon is always in control, operating the robot's instruments using a special controller and foot pedals, similar to how they would use their own surgical tools.

Why is this study being done?

This study is the first to test if using a robot for the delicate stitching in human corneal transplants can make the surgery better, potentially improving patients' vision and recovery.

Will this surgery cost me more?

The study will look at the cost of using the robot. Your participation costs should be covered, and you should not be charged extra for being part of the research and receiving this particular treatment.

How to find out more

Alexandre DENOYER

adenoyer@chu-reims.fr 0326787888 Official trial record

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