JUN 09, 2022
The feasibility and safety of robot-assisted surgery were evaluated as part of an overall effort to improve existing surgical procedures.
This is a double-armed, randomized clinical trial with 6 patients in the robot-assisted arm and 6 patients in the standard-of-care manual control arm. All surgeries took place at the Oxford Eye Hospital and were performed for acute vision loss due to subfoveal hemorrhage from neovascular AMD. All patients received standard vitrectomy followed by intraoperative OCT-guided subretinal tissue plasminogen activator (tPA) injection by robot-assisted or manual technique. The robotic system used was the Preceyes Surgical System, which involves a motion controller that holds the surgical instruments and an instrument manipulator that the surgeon uses to direct the motion controller.
The total surgery duration, the time needed for subretinal tPA injection, retinal trauma, and post-operative 1-month visual acuity were similar between the 2 arms. The median number of retinotomies performed was 1 (range 1–3) in the robot-assisted arm and 2 (range 1–3) in the manual group. All patients tolerated the procedures, and all but 1 patient in the control arm had a successful displacement of hemorrhage at 1 month.
The 3 surgeons involved in the robot-assisted technique and the 2 performing the manual technique were different except for 1 surgeon, which may confound results due to surgeon factors. While total surgery duration was the same, there may be extra time involved in the setting up of the Preceyes system that adds to surgery turnover time.
This is a proof-of-concept study on the use of robot-assisted subretinal drug delivery for patients with subretinal hemorrhages. While no benefits were seen compared to the standard-of-care manual technique, this study did show that robot-assisted surgery with the Preceyes system is feasible and safe compared to the manual technique. Future applications may include subretinal delivery of gene or stem cell therapy.