Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study

Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study

Peter Heiner,1 Edoardo Ligabue,2 Alex Fan,3 Dennis Lam31Vision Eye Institute, Southport, QLD, Australia; 2Ophthalmic Center, San Siro Clinic, Milan, Italy; 3Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong KongPurpose: To evaluate t...

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Autores principales: Heiner P, Ligabue E, Fan A, Lam D
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2014
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Ophthalmology
RE1-994
Acceso en línea:https://doaj.org/article/705eff6caeec4e279384c016bec71ec0
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spelling oai:doaj.org-article:705eff6caeec4e279384c016bec71ec02021-12-02T02:57:29ZSafety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study1177-5483https://doaj.org/article/705eff6caeec4e279384c016bec71ec02014-03-01T00:00:00Zhttp://www.dovepress.com/safety-and-effectiveness-of-a-single-piece-hydrophobic-acrylic-intraoc-a16224https://doaj.org/toc/1177-5483 Peter Heiner,1 Edoardo Ligabue,2 Alex Fan,3 Dennis Lam31Vision Eye Institute, Southport, QLD, Australia; 2Ophthalmic Center, San Siro Clinic, Milan, Italy; 3Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong KongPurpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.Subjects and methods: This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.Results: In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.Conclusion: This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.Keywords: cataract surgery, glistenings, IOL, MX60Heiner PLigabue EFan ALam DDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 629-635 (2014)
institution DOAJ
collection DOAJ
language EN
topic Ophthalmology
RE1-994
spellingShingle Ophthalmology
RE1-994
Heiner P
Ligabue E
Fan A
Lam D
Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
description Peter Heiner,1 Edoardo Ligabue,2 Alex Fan,3 Dennis Lam31Vision Eye Institute, Southport, QLD, Australia; 2Ophthalmic Center, San Siro Clinic, Milan, Italy; 3Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, New Territories, Hong KongPurpose: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL) (enVista® MX60; Bausch and Lomb Incorporated, Rochester, NY, USA) following implantation to correct aphakia subsequent to extracapsular cataract extraction in adults.Subjects and methods: This was an open-label, non-interventional, observational study conducted in 19 university and private-practice settings in Europe and the Asia-Pacific region to investigate clinical outcomes of the MX60 IOL in standard practice. Eligible subjects were at least 18 years of age and had undergone standard phacoemulsification and extracapsular cataract extraction with implantation of the MX60 IOL. The primary safety endpoint was the occurrence of adverse events, and the primary effectiveness endpoints included visual and refractive outcomes and stability, with data collected up to 2 years post-procedure.Results: In this multicenter study, pooled data of 255 eyes were collected and analyzed. Excellent visual and refractive outcomes and stability were demonstrated. At postoperative visit 4 (61–180 days postoperative), 62.2% of subjects achieved a Snellen best-corrected distance visual acuity (CDVA) of 20/20 (decimal 1.00), and 97.8% of subjects achieved a CDVA of 20/40 (decimal 0.50) or better. One eye (1.0%) underwent neodymium:yttrium aluminum garnet capsulotomy at 12 months post-procedure. No glistenings of any grade were reported for any subject at any visit. Adverse events were infrequent and were consistent with incidences generally reported with cataract surgery.Conclusion: This study, which enrolled all comers, provided evidence of the excellent safety and effectiveness of the MX60 IOL in standard practice. Favorable clinical outcomes included outstanding visual and refractive outcomes and stability. No glistenings were reported at any postoperative visit.Keywords: cataract surgery, glistenings, IOL, MX60
format article
author Heiner P
Ligabue E
Fan A
Lam D
author_facet Heiner P
Ligabue E
Fan A
Lam D
author_sort Heiner P
title Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
title_short Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
title_full Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
title_fullStr Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
title_full_unstemmed Safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (enVista®) – results of a European and Asian-Pacific study
title_sort safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (envista®) – results of a european and asian-pacific study
publisher Dove Medical Press
publishDate 2014
url https://doaj.org/article/705eff6caeec4e279384c016bec71ec0
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