Robotic Retinal Dissection Device Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment

NCT06818721

Retinal Detachment Rhegmatogenous Proliferative Vitreoretinopathy

NOT_YET_RECRUITING PHASE2

Scleral Self-indentation Chandelier-assisted Peripheral Vitrectomy Under Air Rhegmatogenous Retinal Detachment.

NCT03218371

Retinal Detachment

COMPLETED

Comparision of Retinal Surgery by Three-dimensional Heads-up Display to the Standard Operating Microscope

NCT03075852

Comparison of 3D Visualization and Microscope for VR Surgery

COMPLETED

Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria

NCT02871531

Rhegmatogenous Retinal Detachment

UNKNOWN NA

Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter

NCT05710458

Vitrectomy Epiretinal Membrane Macular Hole +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epiretinal Membrane Retinal Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Robot assisted surgery

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).