- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03052881
Robotic Retinal Dissection Device Trial (R2D2)
June 16, 2020 updated by: University of Oxford
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 9DU
- University of Oxford
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Robot assisted surgery
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.
|
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.
|
NO_INTERVENTION: Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-operative retinal micro-trauma
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of robotic assisted surgery compared to standard surgery
Time Frame: Intra-operative i.e. 1 day.
|
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.
|
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.
Time Frame: Intra-operative i.e. 1 day.
|
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.
|
Intra-operative i.e. 1 day.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert E MaLaren, DPhil FRCOphth, University of Oxford
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2016
Primary Completion (ACTUAL)
July 23, 2019
Study Completion (ACTUAL)
August 31, 2019
Study Registration Dates
First Submitted
January 4, 2017
First Submitted That Met QC Criteria
February 9, 2017
First Posted (ACTUAL)
February 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 18, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/LO/005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Anonymised data may be shared with other researchers as per Study Protocol and Research Participant Consent form.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epiretinal Membrane
-
Medical University of GrazCompletedEpiretinal Membrane of Both EyesAustria
-
Centre Hospitalier Universitaire DijonTerminatedEpiretinal Membrane SurgeryFrance
-
University of RegensburgCompletedIdiopathic Epiretinal Membrane, CataractGermany
-
Centre Hospitalier Universitaire DijonCompletedEpiretinal Membranes
-
Centre Hospitalier Universitaire DijonRecruitingSurgery for Cataract | Surgery for and Idiopathic Epiretinal MembraneFrance
-
Vienna Institute for Research in Ocular SurgeryCompleted
-
The Ludwig Boltzmann Institute of Retinology and...Completed
-
Nantes University HospitalCompleted
-
IRCCS Policlinico S. MatteoCompleted
-
Changhua Christian HospitalCompletedEpiretinal Membrane | Internal Limiting Membrane WrinklingTaiwan
Clinical Trials on Robot assisted surgery
-
Institut Paoli-CalmettesNot yet recruiting
-
City of Hope Medical CenterNational Cancer Institute (NCI)SuspendedDisease or DisorderUnited States
-
Changhai HospitalUnknownNephrectomy | Robotic Surgical Procedures | ProstatectomyChina
-
The Affiliated Hospital of Qingdao UniversityRecruitingProstate Cancer | Bladder Cancer | Renal CancerChina
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingGynecologic Cancer | Endometrial Neoplasms | Obesity, Morbid | Endometrial Cancer | Gynecologic Disease
-
Instituto do Cancer do Estado de São PauloUnknownHead and Neck Cancer | Gastric Cancer | Pancreatic Cancer | Esophageal Cancer | Lung Cancer | Rectal Cancer | Prostate Cancer | Bladder Cancer | Renal Cancer | Uterus CancerBrazil
-
Kyungpook National University HospitalUnknownRectal CancerKorea, Republic of
-
Southwest Hospital, ChinaRecruiting
-
Taichung Veterans General HospitalNot yet recruitingValvular Heart Disease | Coronary Bypass Graft StenosisTaiwan
-
Société Française d'Anesthésie et de RéanimationCompletedRobot-assisted Urological SurgerySpain, France, Belgium