Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study

BACKGROUND: Clareon(®) is a new hydrophobic acrylic optic biomaterial designed for enhanced clarity and greater resistance to glistening. The present study evaluated the effectiveness and safety of a three-piece hydrophobic, monofocal intraocular lens (IOL) Model MA60NM, made of this new optic material. METHODS: In this prospective, multicenter, open-label study, eligible patients aged ≥60 years, underwent a unilateral implantation with IOL Model MA60NM following phacoemulsification. Patients were followed-up for up to 3 years after implantation. Visual outcome and serious adverse events (SAEs, cumulative and persistent) were compared to ISO grid rates (BS EN ISO 11979-7:2006). The primary effectiveness variable was Best Spectacle-Corrected Visual Acuity (BSCVA) at 1-year postoperative follow-up. In addition, posterior capsular opacification (PCO) was assessed qualitatively and graded by slit lamp exam on a 5-point scale at all visits. RESULTS: Overall, 179 and 138 patients completed the 1-year and 3-year postoperative follow-up, respectively. The BSCVA outcomes were better with IOL Model MA60NM than the ISO grid rates with 95.5% of patients at 1 year and 94.2% of patients at 3 years having achieved a BSCVA of 20/40 or better vs 92.5% in ISO grid. The incidence of cumulative or persistent SAEs was lower after Model MA60NM implantation than the ISO grid reference. The incidence of clinically significant PCO was 1.1% at the 1-year and 2.2% at the 3-year visit. Posterior capsulotomy rate was 1.1% at 1 year and 1.4% at 3 years. CONCLUSION: The three-piece hydrophobic, monofocal IOL Model MA60NM was effective for the visual correction of aphakia and successfully met all the safety parameters as defined by the ISO criteria. PCO and posterior capsulotomy rates were low over the 3-year follow-up period. This study provides evidence and supports the long-term safety and effectiveness of the new optic biomaterial Clareon(®).