determine the safety and effectiveness of the device.
To perform a field observation study using the newly developed EVA Nexus vitrectomy device. Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery
Study Type
OBSERVATIONAL
Enrollment
250
Eva Nexus vitrectomy device
UZ Leuven
Leuven, Belgium
to evaluate the intra-operative safety of a new surgical device
specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.
Time frame: 2 days
To evaluate the possible reduction of total surgical time
The time that was required to prepare the EVA Nexus will be recorded (connecting of supplies + priming).
Time frame: 1 day
To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure
The surgical parameters include a range of data collected on the following: Aspiration Irrigation / Infusion BSS Usage Vitrectomy Ultrasound Illumination Diathermy Micro-injection Silicone oil injection / extraction Laser
Time frame: 2 days
To evaluate possible (S)AE that may be related to the use of the surgical platform.
Rarely, adverse events (AE) that are related to the surgery may only become visible the day after the surgery. A postoperative check of the eye at the day after the surgery will be performed to determine the presence of such AE's.
Time frame: 2 days
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