Surgical Outcomes of a Novel Non-diffractive, Extended Depth-of-focus Intraocular Lens - Preliminary Results From a Phase 4 Study

Purpose: Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) is a new generation extended depth of focus (EDOF) intraocular lens (IOL) that provides continuous vision at various distances. The aim of this study was to present the first results of the EDOF IOL. Materials and Methods: This was a phase-4 retrospective cohort study. A total of 118 eyes of 59 patients data were reviewed. Mean aged of patients 66.62 ± 9.57 years (ranging, 32 - 84 years) with cataracts underwent bilateral implantation of Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) (EDOF IOLs). The follow-up occurred on days 7 to 14, as well as at 2 months and 6 months post-treatment. The main goals included investigating monocular and binocular depth of focus at 6 months after surgery, uncorrected and best corrected distance, intermediate and near visual acuity (VA) up to 6 months following surgery, photopic and mesopic contrast sensitivity. Results: A total of 59 patients with 118 eyes were included in the final analysis. Depth of focus with a monocular vision was observed across various threshold values, including 0.1 log MAR (+0.43 to -0.47 D), 0.2 log MAR (+0.73 to -0.9 D), and 0.3 log MAR (+1.05 to -1.72 D). Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) had values of 0.1 log MAR (+0.52 to -0.58 D), 0.2 log MAR (+1.07 to -1.54 D), and 0.3 log MAR (+1.50 to -2.07 D) in terms of binocular depth of focus. Throughout all follow-up periods, there was a statistically significant improvement in distance, intermediate, and near VA when compared to the preoperative period (p <0.0001). All patients showed an improvement in refraction compared to the baseline measurement. Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) patients exhibited high contrast sensitivity and the EDOF lens demonstrated good results without use of glasses. Mesopic values were relatively lower than photopic values (p<0.05). At 6 months, all IOLs were properly aligned without any instances of tilting. No general safety concerns were expressed in any patient. Conclusion: The Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) EDOF IOLs demonstrated favorable vision outcomes, showing similar VA across various distances. Enova ADVANCED ^TM (VSY BIOTECHNOLOGY) provides a wide monocular depth of focus at 0.1 and 0.2 log MAR. The levels of spectacle independence and patient satisfaction were noticeably higher.