Abstract
Purpose :
To assess the safety and efficacy of an assistive teleoperated robotic system for operating on the retina in patients undergoing vitreoretinal surgery in a prospective randomised clinical trial.
Methods :
Twelve patients requiring removal of the internal limiting membrane (ILM) or epiretinal membrane (ERM) under general anaesthesia were recruited into a prospective randomised clinical trial sponsored by the University of Oxford (research ethics approval: 16/LO/0056). Patients were randomised into two groups of six, having either surgery with the robot or the standard human manual approach. The robotically assisted task was executed by the surgeon manipulating a motion controller located at the edge of the surgical field on the temporal side. The motion controller input was used to control micromanipulations of the surgical instrument through a valved 23G trocar at the pars plana. Increased precision was achieved by scaling and filtering of the surgeon’s motion input - adjusted during surgeon training. The comparative task was the initiation of a flap at the onset of a retinal peel. Results were scored by the number of haemorrhages induced, the number of touches to the retina and the time from entry into the eye to the first successful elevation of the membrane.
Results :
In all patients, surgery was performed successfully without complications. In the robot group, the total number of retinal micro-haemorrhages was 2 and retinal touches 1, compared with 5 and 2 respectively in the manual group. The mean time taken to lift the membrane was 213±51 secs in the robot group and 130±118 secs in the manual group. Use of a chandelier light pipe facilitated complete touch free surgery. The robot allowed hovering directly over the membrane with pre-set motion increments in the Z-axis (to a minimum of 10 μm), allowing precise engagement of the inner retina to lift a membrane flap. Safety was enhanced by the incorporation of a Z-axis motion limit set at any desired intraocular location by the surgeon to avoid inadvertent instrument advancement.
Conclusions :
To our knowledge, we report the first use of a robot to operate inside the human eye. All operations were performed safely and without complications. The extreme precision and stability of a robotic system may facilitate complex retinal and transretinal procedures, such as the controlled delivery of gene therapy and stem cells in future clinical treatments for retinal disease.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.