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

Andrew Maxwell,1 Rajaraman Suryakumar2 1California Eye Institute, Fresno, CA, USA; 2Alcon Laboratories Inc., Fort Worth, TX, USA Background: Clareon® is a new hydrophobic acrylic optic biomaterial designed for enhanced clarity and greater resistance to glistening. The present study evaluat...

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Autores principales:	Maxwell A, Suryakumar R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Best spectacle-corrected visual acuity effectiveness posterior capsule opacification ND:YAG capsulotomy long-term safety Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/a8ad04902e3d48089a8460657a4c06d8
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spelling	oai:doaj.org-article:a8ad04902e3d48089a8460657a4c06d82021-12-02T08:48:45ZLong-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study1177-5483https://doaj.org/article/a8ad04902e3d48089a8460657a4c06d82018-10-01T00:00:00Zhttps://www.dovepress.com/long-term-effectiveness-and-safety-of-a-three-piece-acrylic-hydrophobi-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Andrew Maxwell,1 Rajaraman Suryakumar2 1California Eye Institute, Fresno, CA, USA; 2Alcon Laboratories Inc., Fort Worth, TX, USA 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®. Keywords: Best Spectacle-Corrected Visual Acuity, effectiveness, posterior capsule opacification, ND:YAG laser capsulotomy, long-term safetyMaxwell ASuryakumar RDove Medical PressarticleBest spectacle-corrected visual acuityeffectivenessposterior capsule opacificationND:YAG capsulotomylong-term safetyOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 2031-2037 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Best spectacle-corrected visual acuity effectiveness posterior capsule opacification ND:YAG capsulotomy long-term safety Ophthalmology RE1-994
spellingShingle	Best spectacle-corrected visual acuity effectiveness posterior capsule opacification ND:YAG capsulotomy long-term safety Ophthalmology RE1-994 Maxwell A Suryakumar R 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
description	Andrew Maxwell,1 Rajaraman Suryakumar2 1California Eye Institute, Fresno, CA, USA; 2Alcon Laboratories Inc., Fort Worth, TX, USA 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®. Keywords: Best Spectacle-Corrected Visual Acuity, effectiveness, posterior capsule opacification, ND:YAG laser capsulotomy, long-term safety
format	article
author	Maxwell A Suryakumar R
author_facet	Maxwell A Suryakumar R
author_sort	Maxwell A
title	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
title_short	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
title_full	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
title_fullStr	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
title_full_unstemmed	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
title_sort	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
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/a8ad04902e3d48089a8460657a4c06d8
work_keys_str_mv	AT maxwella longtermeffectivenessandsafetyofathreepieceacrylichydrophobicintraocularlensmodifiedwithhydroxyethylmethacrylateanopenlabel3yearfollowupstudy AT suryakumarr longtermeffectivenessandsafetyofathreepieceacrylichydrophobicintraocularlensmodifiedwithhydroxyethylmethacrylateanopenlabel3yearfollowupstudy
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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

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