Eva Nexus - Phaco Performance Study

To investigate a novel phacoemulsification system "EVA NEXUS" (D.O.R.C., Dutch Opthalmic Research Center) in comparison to an existing system "EVA" in clinical use. An improved software with "Smart IOP Feature" continuously controls intraocular pressure and regulates it by automatically adjusting the irrigation fluid. In addition, further development of the surgical instruments allows access to the eye through even smaller incisions than before. This study compares both phacoemulsification systems in terms of efficiency, safety and postoperative inflammatory activity.

Department of Ophthalmology, University Hospital, LMU Munich, Munich, Germany

In this ongoing study standardized cataract surgery is performed on both eyes of the study participant, using the "EVA" on one eye and the "EVA NEXUS" on the other eye. Only patients with cataract LOCS Grading 1-3 and no accompanying eye diseases were included in this study. A total of 25 patients will be included in this study, with each treatment arm including 25 eyes. During surgery a 0.1ml aqueous humor sample is collected before and after phacoemulsfication to measure the total prostaglandin concentrations using an enzyme-linked immunoassay. An additional flare meter is used at the postoperative study visits to evaluate the anterior chamber flare. Endothelial cell count as well as visual and refractive outcomes were evaluated.

To date, this study comprised 13 patients. The preliminary results show no difference between both groups in postoperative prostaglandin levels in the aqueous humor, being relatively low in both groups. However, postoperative anterior chamber flare, measured with a flare meter, seems to be lower in the intervention group treated with the NEXUS system. Secondary study endpoints including the effective phacoemulsification time (EPT) and endothelial cell los show a slight tendency towards the intervention group (NEXUS).

Overall, both systems show a high level of safety and efficiency with similar results regarding postoperative prostaglandin levels as well as visual and refractive outcomes. However, as far as the preliminary data allow to conclude, the "EVA NEXUS" system is superior to the previous model causing less postoperative anterior chamber inflammation measured with a flare meter and could therefore have a protective effect on the endothelium. Final data will be presented at the congress.