AcuSurgical has reached an important clinical milestone with the publication of the first peer-reviewed clinical study of the LUCA robotic system in RETINA.
The prospective first-in-human study reports the initial clinical experience with LUCA in vitreoretinal surgery and provides the first published clinical evidence supporting the system’s safety, feasibility and performance in patients.
First clinical experience with LUCA
The study included seven patients undergoing surgery for epiretinal membrane or macular hole. LUCA was used to create a posterior vitreous detachment and perform core vitrectomy.
The results represent an important step in the clinical development of the technology:
- No device-related adverse events or serious adverse events
- No accidental retinal touches, hemorrhages or iatrogenic retinal tears related to the robotic system
- Robotic-assisted surgery was successfully completed according to plan in 6 of 7 patients
For AcuSurgical, the publication marks the transition from first-in-human experience to peer-reviewed clinical evidence and represents another step toward the integration of robotics into vitreoretinal surgery.
A collaborative achievement
This milestone would not have been possible without the commitment and expertise of Dr. Fanny Nerinckx, Maxim Van Slycken, Julie Van Puyvelde and Prof. Bart Leroy, together with the entire team at Ghent University Hospital and the AcuSurgical team who contributed to the development and clinical evaluation of LUCA.
The publication comes as AcuSurgical continues the clinical development of LUCA, with the second part of the first-in-human study starting soon and a pivotal study in preparation.
Read the full publication: https://pubmed.ncbi.nlm.nih.gov/42566755/
Nerinckx F, Van Slycken M, Van Puyvelde J, Leroy B. Telemanipulated Robot-Assisted Vitreoretinal Surgery: Safety and Effectiveness of the Luca™ System in robotically performed core vitrectomy in ERM or Macular Hole Surgical Treatment Safety and feasibility of Luca™ System. Retina. Published online August 7, 2026. doi:10.1097/IAE.0000000000004958