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.

Abstract

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). 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. 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. 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.