Microsurgical Robot-assisted Corneal Transplant

NCT06844123 | Recruiting

• 1 other identifier: PS25009*
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Corneal Dystrophy

Outcome Measures

Primary Outcomes (2)

• Descriptive analysis of unusual events intra- and postoperatively

  Number and percentage of unusual events

  Day O (intraoperative) to Day 7

• Descriptive analysis of unusual events

  Number and percentage of unusual events

  Day 7 to Day 90

Secondary Outcomes (9)

• Postoperative corneal anatomical result

  Day 90

• Visual acuity with correction

  Day 90

• Visual acuity without correction

  Day 90

• Corneal topographic regularity

  Day 90

• Corneal topographic regularity

  Day 90

Study Arms (1)

Robot-assisted keratoplasty group

EXPERIMENTAL

patients undergoing robot-assisted corneal transplantation

Procedure: Robot-assisted keratoplasty

Interventions

Robot-assisted keratoplasty PROCEDURE

Feasibility 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

Robot-assisted keratoplasty group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alexandre DENOYER

CONTACT

0326787888; adenoyer@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 25, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

FR (1)