Robotic Retinal Dissection Device Study
Research type
Research Study
Full title
Robotic Retinal Dissection Device Study (R2D2)
IRAS ID
181795
Contact name
Robert MacLaren
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research
This trial will be a prospective interventional surgical case series to pilot the use of a robotic device in retinal surgery. Specifically, the investigators will determine whether particular operations are performed more quickly and safely with robotic assistance.\n\nThe PRECEYES Surgical System is a robotically assistive device developed by PRECEYES Medical Robotics, a Dutch-based research group at the Technische Universiteit Eindhoven. It has been designed to enhance surgical precision, specifically for vitreoretinal eye surgery. The device provides accuracy beyond human capabilities of <10µm in all directions (x, y, z planes). The surgeon is always in control of the instrument by manipulating the motion controller. A video of the device can be viewed at: https://www.youtube.com/watch?v=0Fu8O9wIY5g\n\nPatients undergoing one of two operations will be invited to enroll in the study (i.e. consent for the following operations is an eligibility criteria for the study itself): i) those undergoing epiretinal or inner limiting membrane peel, ii) those undergoing subretinal haemorrhage displacement surgery. The study will involve the surgeon performing specific surgical steps of these operations, that require very high levels of precision, with the assistance of the robot. Efficiency, accuracy and safety data will be collected. Eligible study participants will be recruited from the cohort of patients attending the outpatient clinics of the Oxford Eye Hospital who require either ERM/ILM peel or subretinal haemorrhage displacement surgery. The expected duration and frequency of pre- and post-operative follow up will be identical to standard NHS care for these particular operations i.e. no additional study visits or procedures will be required.Summary of Results
On 31 August 2016, the first person in the world underwent robotic eye surgery in an operation conducted by Prof Robert MacLaren at the John Radcliffe Hospital in Oxford. The operation used a remotely controlled robot to dissect a membrane 100th of a millimetre thick, which was distorting his vision, off the retina of his right eye – an extremely delicate operation that is a very demanding procedure for a surgeon to do safely by hand. The robotic surgical device was developed by PRECEYES BV, a Dutch medical robotics firm established by the University of Eindhoven.This pilot trial, known as the Robotic Retinal Dissection Device (R2D2) study, was funded by an NIHR Senior Investigator award and supported by the NIHR Clinical Research Network (Thames Valley and South Midlands), and compared clinical outcomes in patients using robotic surgery versus manual surgery. In the first phase of the trial, the robotic surgical device was used to peel membranes off the delicate retina without damaging it. The second phase of the trial used the robotic surgical device to place a fine needle under the retina for therapeutic injections. In both phases, the robotic surgery was shown to be safe and effective.
The positive outcomes of the study were published in Nature Biomedical Engineering in 2018 (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVwF9GF26HVDCRt-2Fvvs6f3GYbAa685N06iI4ZxQciveuyFo00sFr-2FmA-2BAU4TAHKN9A-3D-3Dl9AA_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK1CESlnIetgfXA9qasGGrKY2Jglz7pzOZL9JyGpLYkXc830R8tWodPOM3Lfsb8HF2SMO13CE-2BeFOp3UafUla3uWXN27F5wXi-2BSSRiWeLMfvxI2TZmoVaz74lp1xZL0SVAiv9LwtCgay4vH1U5NqP3ZGytCCAXdsqqTMZ82QZRv6A-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C36ff9f85d1764627ff3008d9c465700f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637756762210746191%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=vRX65XUoPiJs8FMl08LK%2FnXdFKPKAtx5sYQNL63aZno%3D&reserved=0 and the American Journal of Ophthalmology in 2021 (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbaNKhM2veQCpNbb8U3lc6HR-2FFGtL43QZKx2BsnHn-2B0tjrVg0bcdkRZhlc5-2F-2BZevq7g-3D-3DpQ2g_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK1CESlnIetgfXA9qasGGrKLGfUFJD3FQtb8PL-2F6Rz7m8yVOkSKYxWxxtgNH1WVIMkSs7-2F4NrBy6PyQdcd50k2Cue4W7-2Fj843wD5bZ-2B6BZs2UjOU7N-2BCk52uqjpcspsBkBanOxTA8cjPUnhPPs7-2FDm-2Fjkel0VqBDhOfOeR2nXcMyw-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C36ff9f85d1764627ff3008d9c465700f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637756762210746191%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=Qgg3yeZlZuB5R9cqw%2F2OsNtMT3QoS4GEKLv30jsQ2n4%3D&reserved=0
This first-in-man use of a robot to operate inside the eye generated a great deal of public interest. The first operation, in which a membrane one hundredth of a millimetre thick was successfully removed from the retina of a visually impaired patient, was featured by the BBC (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbc2HlegGjjA31J1p56RPy1dfycsW4VlNacDhiOevZR2rvd8o_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YK1CESlnIetgfXA9qasGGrK9HF3kpAM6Yzl47co7KDo8-2BvGDdJCHDYQZ828OuZnMyIHSVgcaHEm-2FRIn8BRmbmOg9wQl2TEx8Jyr4-2B-2BIu2nsYf7Ocjb7I3QwsDbiW-2Frde-2F0NwSI4BVHI3YQhYdiKc7hSy7mYwA5mb4fLAObWe-2Bk6OQ-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C36ff9f85d1764627ff3008d9c465700f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637756762210746191%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=QQI4ZyJNGzObQJCKee6bQS8%2FggR3nlde27vEmeDVti4%3D&reserved=0 Prof Robert MacLaren’s pioneering use of robotic eye surgery was also included by the BBC as one of its medical breakthroughs of 2016 (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bbc.com%2Fnews%2Fav%2Fhealth-38458255&data=04%7C01%7Capprovals%40hra.nhs.uk%7C36ff9f85d1764627ff3008d9c465700f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637756762210746191%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=WXSMqjp1HnF%2BHre%2BSDIq3jwc%2BjGgRZCO8QegWld4iLo%3D&reserved=0). Additionally the Daily Telegraph mentioned the robotic eye surgery as one of the top 8 robotic healthcare breakthroughs in its STEM Awards 2018 (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.telegraph.co.uk%2Feducation%2Fstem-awards%2Finnovation%2Frobotic-healthcare-breakthroughs%2F&data=04%7C01%7Capprovals%40hra.nhs.uk%7C36ff9f85d1764627ff3008d9c465700f%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637756762210746191%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=Eps4dJcGvosM0%2Fga6WU%2BzImmgLq7vP2VPxEUaN2Z9ZY%3D&reserved=0).
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0056
Date of REC Opinion
12 Feb 2016
REC opinion
Further Information Favourable Opinion