EVA Nexus Vitrectomy Device Field Observation Study

EVA Nexus Field Observation Study. A Monocentric, Academic Field Observation Study of a Prototype of a New CE-labeled Vitrectomy Device Developed by DORC BV (The Netherlands).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05229094

Enrollment

250

Registered

2022-02-08

Start date

2021-05-22

Completion date

2022-04-01

Last updated

2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retina Disorder, Vitreous Disorder

Brief summary

determine the safety and effectiveness of the device.

Detailed description

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

Interventions

DEVICEEva Nexus

Eva Nexus vitrectomy device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Inclusion criteria

* Patients that are scheduled for intra-ocular surgery regardless of the indication: * Vitrectomy surgery * Cataract surgery * Vitrectomy combined with cataract surgery * In case of (combined) vitrectomy: primary or repeat vitrectomy * General or retrobulbar anesthesia, the latter can be combined with sedation * Patients aged ≥ 18 years

Exclusion criteria

* Patients aged \< 18 years

Design outcomes

Primary

Measure	Time frame	Description
to evaluate the intra-operative safety of a new surgical device	2 days	specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.

Secondary

Measure	Time frame	Description
To evaluate the possible reduction of total surgical time	1 day	The time that was required to prepare the EVA Nexus will be recorded (connecting of supplies + priming).
To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure	2 days	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
To evaluate possible (S)AE that may be related to the use of the surgical platform.	2 days	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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026