First-in-human study of the safety and viability of intraocular robotic surgery

Abstract

Microsurgery of the retina would be dramatically improved by instruments that offer supra-human precision. Here, we report the results of a first-in-human study of remotely controlled robot-assisted retinal surgery performed through a telemanipulation device. Specifically, 12 patients that required dissection of the epiretinal or inner limiting membrane over the macula were randomly assigned to either undergo robot-assisted surgery or manual surgery, under general anaesthesia. We evaluated surgical success, the duration of surgery and the amount of retinal microtrauma as a proxy for safety. Surgical outcomes were equally successful in the robotic surgery and manual surgery groups. Differences in the amount of retinal microtrauma between the two groups were statistically insignificant, yet dissection took longer with robotic surgery (median time: 4 min 55 s) than with manual surgery (1 min 20 s). We also show the feasibility of using the robot to inject recombinant tissue plasminogen activator under the retina to displace sight-threatening haemorrhage in three patients under local anaesthesia. A safe and viable robotic system for intraocular surgery would enable precise and minimally traumatic delivery of gene therapy or cell therapy to the retina.

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Fig. 1: The operating room floor plan for a right-eye patient.
Fig. 2: Robotic set-up.
Fig. 3: Docking of the instrument manipulator with the conical scleral port adaptor.
Fig. 4: Objective outcome measures: manual (control) versus robot-assisted retinal membrane peels.
Fig. 5: Pre-operative and post-operative OCT.

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Acknowledgements

We acknowledge funding from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, Zien Zonder Zorgen (ZIZOZ)—a Dutch charity—and the Nuffield Medical Fellowship.

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Authors

Contributions

T.L.E. was a surgeon in the study, conceived the study design, conducted participant recruitment and wrote and reviewed the manuscript. K.X. conducted participant recruitment, conceived the study design, performed the data recording, generated the figures and wrote and reviewed the manuscript. H.C.M.M. and M.J.B. were robotics/software engineers, designed and constructed the Preceyes Surgical System, conducted the robot system training, conceived the study design and implementation, edited the videos and wrote and reviewed the manuscript. G.J.L.N. conceived the study design and wrote and reviewed the manuscript. M.P.S. conceived the study design and reviewed the manuscript. M.L. was a surgeon in the study and reviewed the manuscript. A.D.F. was an anaesthetist in the study and wrote and reviewed the manuscript. M.D.d.S. designed and conducted the clinical translation of the Preceyes Surgical System and wrote and reviewed the manuscript. R.E.M. was chief surgeon in the study and principal investigator, and wrote and reviewed the manuscript.

Corresponding author

Correspondence to R. E. MacLaren.

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Competing interests

T.L.E., K.X., M.L., R.E.M., M.P.S. and A.D.F. declare no competing interests. H.C.M.M., M.J.B., G.J.L.N. are employed in the robot engineering and development department at Preceyes BV, Eindhoven, the Netherlands, and M.D.d.S. is a shareholder in Preceyes BV.

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Supplementary information

Supplementary Information

Supplementary Notes, Supplementary Figures 1–38, Supplementary Tables 1–7, Supplementary References 1–16.

Reporting Summary

Supplementary Video 1

Tremor comparison between robot-assisted and manual membrane peel under light pipe.

Supplementary Video 2

Tremor comparison between robot-assisted and manual membrane peel under chandelier illumination.

Supplementary Video 3

Subretinal injection of tissue plasminogen activator using a 41G needle and chandelier illumination.

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Edwards, T.L., Xue, K., Meenink, H.C.M. et al. First-in-human study of the safety and viability of intraocular robotic surgery. Nat Biomed Eng 2, 649–656 (2018). https://doi.org/10.1038/s41551-018-0248-4

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