Robotic Retinal Dissection Device Trial
Condition: Epiretinal Membrane; Retinal Hemorrhage
MeSH terms: Epiretinal Membrane; Retinal Hemorrhage; Hemorrhage
Study type: Interventional

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.
    

Intervention name(s): Robot assisted surgery
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: None (Open Label)
Primary purpose: Treatment