First-in-Human Robot-Assisted Subretinal Drug Delivery Under Local Anesthesia

Abstract

Purpose: To report the results of a first-in-human study using a robotic device to assist subretinal drug delivery in patients undergoing vitreoretinal surgery for macular hemorrhage. Design: Double-armed, randomized controlled surgical trial (ClinicalTrials.gov identifier: NCT03052881). Methods: The study was performed at the Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom. In total, 12 participants were recruited—6 in the robot-assisted and 6 in the control manual surgery arm according to the prespecified inclusion and exclusion criteria. All subjects presented with acute loss of vision owing to a subfoveal hemorrhage secondary to neovascular a..