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Completed

NCT Number: NCT05229094

EVA Nexus Vitrectomy Device Field Observation Study

determine the safety and effectiveness of the device.

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Key information

Conditions

Retina Disorder Eye Diseases Retinal Diseases Vitreous Disorder

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eva Nexus

Device

Eva Nexus vitrectomy device

Primary outcomes

  1. to evaluate the intra-operative safety of a new surgical device

    Time frame: 2 days

    specific adverse events that may occur during the (phaco) vitrectomy will be recorded to assess the surgical safety.

Secondary outcomes

  1. To evaluate the possible reduction of total surgical time

    Time frame: 1 day

    The time that was required to prepare the EVA Nexus will be recorded (connecting of supplies + priming).

  2. To evaluate the impact of usage of the EVA NEXUS on the surgical parameters used during the procedure

    Time frame: 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

  3. To evaluate possible (S)AE that may be related to the use of the surgical platform.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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).

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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