Microsurgical Robot-assisted Corneal Transplant

Recruiting now · Not applicable

Conditions studied: Corneal Dystrophy

In brief

Full-thickness corneal grafting (transfixing keratoplasty) is a tissue graft described at the beginning of the 20th century, which has remained technically unchanged for several decades. Around 900 transfixing keratoplasties are performed every year in France. This microsurgical procedure is intended for patients with severe corneal pathology that seriously impairs visual function, and for whom no therapeutic alternative - optical devices, medication or other surgical procedure - exists. The initial anatomical outcome of surgery depends on the accurate execution of the corneal sutures. Very recently, a robot with microsurgical capabilities was developed by the MMI company (Symani® surgical system, now available from the Reims University Hospital). This robot is equipped with forceps and a needle holder capable of handling fragile tissues and microsurgical needles with an amplitude of movement greater than that of the human hand. It is operated by a surgeon via a wireless controller and foot pedal. It could thus be used to perform the usual sutures of a transfixing keratoplasty. To our knowledge, no study to date has evaluated the contribution of a microsurgical robot to transfixing keratoplasty in humans. The Symani® microsurgical robot recently received CE marking for microsurgery. The investigators were able to carry out a series of ex vivo keratoplasties using the robot to suture non-conforming human corneas (destined for destruction), thus proving the feasibility of the procedure. On the basis of this proof of concept, our project aims to evaluate the performance of robot-assisted transfixing keratoplasty in patients requiring corneal transplantation. Robotic assistance for human eye surgery, particularly corneal transplants, has never been evaluated. The use of a robot to perform corneal sutures during transfixing keratoplasty could equal or even surpass the performance of this crucial surgical step, which is conventionally performed manually. Ultimately, visual results could be equivalent or even better than those obtained after conventional surgery. At the same time, the use of the robot will be evaluated in terms of surgical cost, in order to obtain a quantified financial evaluation of robot-assisted keratoplasty.

Key facts

Study ID

NCT06844123

Run by

CHU de Reims

People needed

10

Starts

2025-06-06

Expected to finish

2027-04-01

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of legal age seen in a specialized ophthalmology consultation at the Reims University Hospital, and requiring transfixing keratoplasty.
• Affiliated to a social security scheme
• Agreeing to take part in the study (information and signature of consent form).

You may not qualify if…

• Patients protected by law
• Patients with an ocular pathology other than their corneal pathology.
• Mentally incapable of adhering to the principles of the study.

Where it is running

• Chu Reims — Reims, France (enrolling)

Full record on ClinicalTrials.gov

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