About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Patients protected by law
Patients with an ocular pathology other than their corneal pathology.
Mentally incapable of adhering to the principles of the study.
Trial design
Single group
Treatments tested in this trial
Robot-assisted keratoplasty
Procedure/SurgeryFeasibility pilot interventional study. Monocentric, one arm. Microsurgical robot will be used to perform penetrating keratoplasty. During the procedure, the corneal sutures will be performed using symani surgical system, that is a microsurgical robot controlled by a surgeon
Treatment groups
Trial outcomes
Primary outcomes
Descriptive analysis of unusual events intra- and postoperatively
Number and percentage of unusual events
Descriptive analysis of unusual events
Number and percentage of unusual events
Secondary outcomes
Postoperative corneal anatomical result
Anterior topographic will be performed and compare central astigmatism
Visual acuity with correction
The mean diopters
Visual acuity without correction
The mean diopters
Corneal topographic regularity
Corneal topographic regularity measured by surface regularity index (SRI)
Sponsors and contacts
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