EVA Nexus Vitrectomy Device Field Observation Study

Retina Disorder Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05229094
• Other study ID #: 64913
• Status: Completed
• Start date: May 22, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: June 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

determine the safety and effectiveness of the device.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Retina Disorder
• Retinal Diseases
• Vitreous Disorder

Intervention

Device:
• Eva Nexus
Eva Nexus vitrectomy device

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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