Clinical trial NCT03052881: Robotic Retinal Dissection Device Trial
Official title: Robotic Retinal Dissection Device Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epiretinal Membrane
Retinal Hemorrhage
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Participant is willing and able to give informed consent for i) participation in the trial ii) for the surgery itself e.g. standard NHS consent form.
2. Males or females aged 18 - 90 years.
3. Standard vitreoretinal operation deemed necessary by the ophthalmologist, specifically: injection of subretinal tissue plasminogen activator for treatment of sub retinal haemorrhage, or peeling of epiretinal and/or inner limiting membrane.
4. Patients must be deemed fit for surgery.
5. In the Investigator's opinion, the participant is able and willing to comply with all trial requirements.
6. Willing to allow his or her General Practitioner or Consultant, to be notified of participation in the trial (not required for the control arm).

Exclusion Criteria:

-

Primary outcomes:
measure: Intra-operative retinal micro-trauma
timeFrame: 3 months
Secondary outcomes:
measure: Duration of robotic assisted surgery compared to standard surgery
timeFrame: Intra-operative i.e. 1 day.
measure: 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.
timeFrame: Intra-operative i.e. 1 day.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Robert E MaLaren, DPhil FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cehajic-Kapetanovic J, Xue K, Edwards TL, Meenink TC, Beelen MJ, Naus GJ, de Smet MD, MacLaren RE. First-in-Human Robot-Assisted Subretinal Drug Delivery Under Local Anesthesia. Am J Ophthalmol. 2022 May;237:104-113. doi: 10.1016/j.ajo.2021.11.011. Epub 2021 Nov 14.