EVA Nexus Vitrectomy Device Field Observation Study

Completed

• Conditions: Retina Disorder; Vitreous Disorder

• Registration Number: NCT05229094
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study Start: 2021-05-22
• Study First Submitted: 2021-12-24
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-08
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium