Clinical trial to test the safety of the EVA Nexus surgical platform.

Abstract

Background: The EVA Nexus system offers several technical improvements over its predecessor. The newly designed Aveta cannula system for vitrectomy surgery avoids the need for removal of the valve from the infusion cannula. The chamfered leading edge of the cannula also reduces the insertion force needed. The new EquiPhaco needles in combination with SmartIOP provide excellent anterior chamber stability during phaco-emulsification surgery, enabling to work at lower infusion pressures, and the multiburst phaco mode allows easier removal of hard cataracts. The system offers a secondary active infusion line for independent control of pressure to the anterior and posterior chambers, monitoring of flow rate/reflux and warning of infusion bottle emptying. This study evaluated whether these technical improvements result in improved surgical safety.

Methods: In total, 250 eyes that underwent vitrectomy (53%) or phaco-vitrectomy (47%) using the EVA Nexus system were prospectively included. The occurrence of intraoperative adverse events was compared to that of historically operated eyes using the EVA system.

Results: The average age of the patients was 63 years. A total of 33% of the patients were operated on for retinal detachment, 17% for macular pucker, 11% for treating floaters, 9% for removing silicone oil, 8% for macular hole repair and 22% for other diseases. In 75% of surgeries, 23 G instruments were used, and 27 G instruments were used in 25% of cases. Device issues that occurred included priming cycle issues (n = 4), eye pressure stability problems (n = 6) and vitrectome performance issues (n = 1), all of which in the first 100 patients who were included and were fixed with software updates. The frequency of surgical complications in the anterior segment was lower than that in the historically recorded surgical reports. Intraoperative events in the posterior segment included hemorrhage from retinal vessels, choroidal hematoma, iatrogenic retinal damage/tear, and subchoroidal infusion. Again, these events occurred rarely and less frequently than in the historical surgical reports.

Conclusions: The EVA Nexus provides a surgical platform that reduces the incidence of intraoperative adverse events and iatrogenic complications in both anterior and posterior segment surgery. This could increase surgical safety during cataract and vitrectomy surgery. TRIAL REGISTRATION NUMBER CLINICALTRIALS.GOV: : NCT05229094 Data 22/5/2021.