Robotic Retinal Dissection Device Trial

NCT03052881 | Completed DMC

• 1 other identifier: 16/LO/005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane; Retinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Duration of robotic assisted surgery compared to standard surgery

  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.

  Intra-operative i.e. 1 day.

Study Arms (2)

Robot assisted surgery

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Robot assisted surgery DEVICE

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.

Robot assisted surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males or females aged 18 - 90 years.
• 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.
• Patients must be deemed fit for surgery.
• In the Investigator's opinion, the participant is able and willing to comply with all trial requirements.
• Willing to allow his or her General Practitioner or Consultant, to be notified of participation in the trial (not required for the control arm).

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34788592 DERIVED

Related Links

• A video of the device can be viewed at this website

MeSH Terms

Conditions

Epiretinal Membrane; Retinal Hemorrhage

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-Assisted; Surgical Procedures, Operative; Robotics; Automation; Technology; Technology, Industry, and Agriculture

Study Officials

• Robert E MaLaren, DPhil FRCOphth

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: February 14, 2017
• Study Start: May 1, 2016
• Primary Completion: July 23, 2019
• Study Completion: August 31, 2019
• Last Updated: June 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)