An interventional study of Robot assisted surgery in Epiretinal Membrane and Retinal Hemorrhage, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by University of Oxford · Not applicable, Interventional, and Treatment
The purpose of the study is to determine whether use of a robotic system improves the precision and therefore safety of high precision steps in retinal surgery. Two common surgical scenarios (ERM/ILM peel and sub retinal haemorrhage displacement surgery) that require a high degree of precision to avoid damage to the retina have been chosen for this trial. These steps also have been selected because they allow a clearly definable outcome measure e.g. time taken to complete a specific step in the operation. The main issue here is that the patients will be undergoing this procedure regardless of enrolment in the trial - the only difference being that for study participants the surgeon will perform parts of the operation with the assistance of the robot.
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. The 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. Patients 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 sub retinal 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.
120 studies on the registry are indexed under Epiretinal Membrane; 14 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 73 interventional studies indexed under Epiretinal Membrane.
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Exclusion Criteria:
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To investigate use of an intraocular robotic system to assist the surgeon in performing one of two operation: i) epiretinal, or inner limiting, membrane peel and ii) displacement of sub macular haemorrhage.
Device: Robot assisted surgery
A control group of patients underwent either i) epiretinal, or inner limiting, membrane peel and ii) displacement of sub macular haemorrhage without the use of a robot i.e. the surgery was done in the standard manner.
The 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.
Intra-operative retinal micro-trauma
To explore the safety of the PRECEYES surgical robot assisted surgeon in two specific eye surgery procedures during steps that require the greatest manual precision. A count of the number of iatrogenic retinal micro-haemorrhages and/or inadvertent instrument touches of the retina will be made. This outcome measure will be assessed at the time of surgery and followed post-operatively using optical coherence tomography scans of the macula.
Time frame: 3 months
Duration of robotic assisted surgery compared to standard surgery
To investigate the speed of the PRECEYES surgical robot assisted surgeon in initiating membrane removal from the retina compared with the standard of care (manual) technique. The duration of steps performed with the assistance of the robot will be compared to the standard operative technique.
Time frame: Intra-operative i.e. 1 day.
Accuracy of instrument positioning in the subretinal space during subretinal injection, measured by visualising the cannula tip position with an integrated optical coherence tomography (OCT) operating microscope.
To investigate the accuracy of the PRECEYES surgical robot assisted surgeon in performing subretinal injection of tissue plasminogen activator (tPA). The cannula tip position will be documented using real-time OCT. Where possible, a comparison to the standard technique will be performed. Deviation in an x, y or z plane from the desired optimal position in the subretinal space will be recorded.
Time frame: Intra-operative i.e. 1 day.
Plan to share: No — Anonymised data may be shared with other researchers as per Study Protocol and Research Participant Consent form.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Oxford