Six patients have successfully undergone an experimental vitreoretinal surgery with the assistance of a robot, marking the first use of this procedure inside a living human eye.
The Robotic Retinal Dissection Device (R2D2) trial compared the standard surgical removal of the internal limiting membrane or the epiretinal membrane with a robotic-assisted approach. Of 12 subjects, 6 received conventional surgery. The other 6 underwent the new robotic technique, performed with a joystick to control a robotic arm that operates instruments through the temporal pars plana. Chandelier illumination was also used to enable a touch-free surgery.
Benefits of the robotic platform include presets that prevent the surgeon from accidentally advancing the instrument or triggering it with hand tremors, and a greater range of motion afforded by 7 independent computer-operated motors.
There were 2 retinal micro-hemorrhages and 1 retinal touch induced in the robot group, compared with 5 and 2, respectively, in the manual group.
"The robot performed numerically better than the human in terms of creating fewer retinal hemorrhages, but the study was not powered sufficiently to show statistically significant results," according to Robert MacLaren, MD, professor of ophthalmology at the University of Oxford, who presented the results at the 2017 Association for Research in Vision and Ophthalmology annual meeting in Baltimore, Maryland.
Co-author Marc D. De Smet, MD, chief medical officer at the Dutch firm Preceyes B. V. that developed the technology, said the robot allows for “10 times” more precision than the unaided human hand, adding that the operation was also safe. None of the 6 patients in the study group experienced any complications.
Robot-assisted surgery did involve longer surgery times, however: on average, the procedure took 213 seconds compared with 130 seconds in the manual group.
“Robotic technology is likely to allow us to do new operations that are currently beyond the capability of the human hand. A robotic system has huge advantages for operations under the retina or for operations in which a long and controlled procedure is required—for instance, when injecting gene therapy or cells under the retina,” Dr. MacLaren told Reuters Health in an email, adding that they plan to start a trial to use the robot for gene therapy applications.