Robot-Assisted Subretinal Drug Delivery in Humans
By Lynda Seminara
Selected by Richard K. Parrish II, MD
Journal Highlights
American Journal of Ophthalmology, May 2022
Download PDF
Cehajic-Kapetanovic et al. conducted a first-in-human randomized controlled study of a robotic device designed to deliver drugs subretinally to patients undergoing vitreoretinal surgery for acute macular hemorrhage. They found that the robotic-assisted procedure was safe and well tolerated. Outcomes resembled those for the manual technique, indicating that robotic technology may have roles in gene and cell therapies that require a high level of precision.
The authors performed this dual-arm intervention trial between August 2016 and March 2020 at Oxford Eye Hospital in Oxford, United Kingdom. They recruited 12 patients who had acute loss of vision from subfoveal hemorrhage associated with neovascular age-related macular degeneration. After standard vitrectomy, tissue plasminogen activator (tPA) was injected in six patients subretinally using the Preceyes Surgical System (with the surgeon manipulating a handheld motion controller in four possible axes). The other six patients received tPA manually under OCT guidance. The robotic procedure involved advancement of a cannula through the retina and foot-controlled injection of up to 100 mL of the tPA solution. Safety was the primary outcome; the researchers also assessed surgical duration, surgical success, and tolerability of the procedure during local anesthesia.
In all patients, the procedures were safe and well tolerated; measurable outcomes were equivalent for both groups. The median number of retinotomy sites was 1 in the robotic arm and 2 in the manual arm. The median volumes of injected tPA were .05 and .100 mL, respectively, and the median durations of delivery were 5.9 and 4.3 minutes, respectively. The mean durations of surgery were 42.7 and 46.9 minutes, respectively. The number of retinal microtraumas, which was a proxy for safety, did not differ significantly between the groups. One month post-op, the median gain in VA was 1.30 logMAR in the robotic group and 1.62 logMAR in the manual group.
The authors acknowledged the limitations of their study, including the small sample and surgeon inexperience with robotic technology. Nonetheless, this work shows proof of concept for robot-assisted subretinal drug delivery and highlights the promise of this technology in the management of retinal degenerative diseases.
The original article can be found here.