Robotic Retinal Dissection Device Trial (R2D2)
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|ClinicalTrials.gov Identifier: NCT03052881|
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epiretinal Membrane Retinal Hemorrhage||Device: Robot assisted surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment|
|Masking:||None (Open Label)|
|Official Title:||Robotic Retinal Dissection Device Trial|
|Actual Study Start Date :||May 1, 2016|
|Actual Primary Completion Date :||July 23, 2019|
|Actual Study Completion Date :||August 31, 2019|
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.
Device: Robot assisted surgery
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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052881
|University of Oxford|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Principal Investigator:||Robert E MaLaren, DPhil FRCOphth||University of Oxford|