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  • 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

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    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.