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).

determine the safety and effectiveness of the device.

Study Overview

• Status: Completed
• Conditions: Vitreous Disorder; Retina Disorder
• Intervention / Treatment: Device: Eva Nexus

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

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that are scheduled for intra-ocular surgery regardless of the indication:

• Vitrectomy surgery
• Cataract surgery
• Vitrectomy combined with cataract surgery

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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.	2 days

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2021
• Primary Completion (ACTUAL): April 1, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Retinal Diseases
• Other Study ID Numbers: 64913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No