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.

PURPOSE: To evaluate the initial safety and feasibility of the Luca™ System, a telemanipulated robotic system with bimanual capabilities, used to perform a Core vitrectomy during surgical treatment of epiretinal membrane (ERM) or macular hole (MH). METHODS: This was a prospective, single-arm, first-in-human study conducted at Ghent University Hospital in Belgium. Seven patients (mean age 71.0 ± 11.5 years) scheduled for vitreoretinal surgery for ERM (n=6) or MH (n=1) were enrolled between February and June 2024. The Luca™ system was used to create a posterior vitreous detachment and to perform a core vitrectomy, after which the remainder of the surgery (e.g., membrane peeling) was completed manually. The primary safety endpoint was the incidence and severity of device-related Adverse Event (AEs). Secondary endpoints included the proportion of subjects with iatrogenic retinal tears and changes in BCDVA and BCNVA. RESULTS: All surgeries were completed without serious safety incidents, and no device-related AEs or serious AEs were reported. No accidental retinal touches, hemorrhages, or iatrogenic retinal tears related to the robotic system occurred. In 6 out of 7 patients (85.7%), the robotic-assisted part of the procedure was successfully completed according to pre-operative planning. At 3 months, 5 out of 7 patients (71.4%) had a BCDVA gain. CONCLUSIONS: The initial clinical experience with the Luca™ robotic system demonstrates a favorable safety, feasibility, and performance profile for vitreoretinal surgery in patients with acquired maculopathies. The safety profile appears comparable to that of manual surgery.