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Microsurgical Robot-assisted Corneal Transplant

NCT06844123 · CHU de Reims · Updated 26 June 2025

What is being tested
Robot-assisted keratoplasty
For
Corneal Dystrophy
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 60 years. About 10 people. The full rules are on the registry page.
Where
France
When
Starts or started 6 June 2025, ends April 2027. Registered 25 Feb 2025.
Results
None posted yet.

In the researchers' words

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…
ClinicalTrials.gov, NCT06844123

Sites

  • Chu ReimsReims, France