First-In-Human Robot-Assisted Subretinal Drug Delivery Under Local Anaesthesia A Randomised Clinical Trial.
Cehajic-Kapetanovic J., Xue K., Edwards TL., Meenink TC., Beelen MJ., Naus GJ., de Smet MD., MacLaren RE.
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 haemorrhage. DESIGN: Double armed, randomized controlled surgical trial (ClinicalTrials.gov identifier: NCT03052881). METHODS: Setting Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom. Participants In total, 12 participants were recruited: 6 in the robot-assisted and 6 in the control manual surgery arm according to the pre-specified inclusion and exclusion criteria. All subjects presented with acute loss of vision due to a sub-foveal haemorrhage secondary to neovascular age-related macular degeneration. Intervention After standard vitrectomy, intraoperative OCT-guided subretinal injection of tissue plasminogen activator (TPA) was performed either by robot-assisted or conventional manual technique under local anaesthesia. The robotic part of the procedure involved advancement of a cannula through the retina and stabilizing it during foot-controlled injection of up to 100µl of TPA solution. Main Outcome Measures We assessed surgical success, duration of surgery, adverse events, and tolerability of surgery under local anaesthesia. RESULTS: The procedure was well tolerated by all participants and safely performed in all cases. Total duration of surgery, time taken to complete the injection and retinal microtrauma were similar between the groups and not clinically significant. Subretinal haemorrhage was successfully displaced at 1-month post-intervention, except for one control subject, and the median gain in visual acuity was similar in both arms. CONCLUSIONS: This first-in-human study demonstrates the feasibility and safety of high precision robot-assisted subretinal drug delivery as part of the surgical management of sub-macular haemorrhage, simulating its potential future application in gene or cell therapy.