Evaluated the performance of PSS assisted surgical steps as compared to manual surgery in at selected stages of macular pucker surgery.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
- Eye therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of the changes in the OCT nerve fiber layer thickness at 3 months
and 6 months post surgery.
Count of the number of retinal surface hemorrhages at the end of the each
procedure, and the number of retinal touches.
Secondary outcome
Differences in a structured satisfaction questionnaire for the patient, surgeon
and OR nurses following each surgery
Surgical time differences
Comparison of the safety profile and rate of complications between the two
types of surgery
Background summary
The Preceyes Surgical System (PSS) is a high precision telemanipulated robot
that assists surgeons at critical steps during vitreoretinal surgery. When
needed during particular surgical steps, the surgeon can make use of the PSS,
while at other time, the surgery is carried out manually. The surgical steps
where PSS can be of assistance require a clinical evaluation. A typical
surgical procedure for vitreoretinal surgeons, where several of the common
surgical steps are carried out is a macular pucker procedure.
Study objective
Evaluated the performance of PSS assisted surgical steps as compared to manual
surgery in at selected stages of macular pucker surgery.
Study design
Prospective comparative study 2:1 randomization between robotic assistance and
manual surgery.
Intervention
Evaluated surgical steps will include: membrane staining, fluid-fluid exchange,
initiation of a flap, peeling, air-fluid exchange, targeted illumination.
Study burden and risks
The main inconvenience will be an increase in time as compared to standard
surgery and the time required for the purpose of recording and documentation.
Participants may benefit from the added precision and accuracy provided by the
PSS.
Den Dolech 2
Eindhoven 5612AZ
NL
Den Dolech 2
Eindhoven 5612AZ
NL
Listed location countries
Age
Inclusion criteria
Epiretinal membrane requiring surgery and confirmed on Spectral OCT scans
BCVA < 0.5
Age * 18 years
Informed consent
Exclusion criteria
Presence of scleral ectasia in the area of trocar placement.
Prior surgery involving the sclera in the zone of trocar placement.
Prior surgery in the previous 3 months.
Myopia > 6 D.
Insufficient transparency of ocular media (e.g. lens opacity, vitreous
haemorrhage) if this will not be removed at the time of surgery
Corneal decompensation or expected decompensation as a result of cataract
surgery
Use of anticoagulants.
Patient unable to follow verbal instructions regarding positioning.
Patient unable to remain quiet and still for the duration of surgery.
Any patient that the surgeon feels is unfit to undergo surgery within this
trial.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66979.078.18 |