Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens

Mark Packer,1 Jon I Williams,2 Gregg Feinerman,3 Richard S Hope2 On behalf of the enVista Toric Clinical Study Group 1Mark Packer MD Consulting, Inc., Boulder, CO, USA; 2Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA; 3Feinerman Vision Center, Newport Beach, CA,...

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Autores principales:	Packer M, Williams JI, Feinerman G, Hope RS
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Human IOL astigmatism cataract Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/e48349c685804bffb3ed98c90af10cdd
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spelling	oai:doaj.org-article:e48349c685804bffb3ed98c90af10cdd2021-12-02T08:14:11ZProspective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens1177-5483https://doaj.org/article/e48349c685804bffb3ed98c90af10cdd2018-06-01T00:00:00Zhttps://www.dovepress.com/prospective-multicenter-clinical-trial-to-evaluate-the-safety-and-effe-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Mark Packer,1 Jon I Williams,2 Gregg Feinerman,3 Richard S Hope2 On behalf of the enVista Toric Clinical Study Group 1Mark Packer MD Consulting, Inc., Boulder, CO, USA; 2Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA; 3Feinerman Vision Center, Newport Beach, CA, USA Purpose: Glistening formation in the intraocular lens (IOL) optic has the potential to impact quality of vision. The enVista One-Piece Hydrophobic Acrylic Spherical IOL Model MX60 (MX60 IOL) is currently the only US Food and Drug Administration-approved IOL with a label of “no glistenings”. The purpose of this prospective, multicenter, partially randomized, partially controlled, double-masked, pivotal study was to evaluate the safety and effectiveness of the enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL). Patients and methods: Subjects (n=191) were implanted with the enVista MX60T Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL (control). Eyes within the lowest range of corneal astigmatism were randomized to receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio. All subjects with corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs received toric IOLs. Rotational stability, cylinder reduction, and best-corrected distance visual acuity were primary effectiveness endpoints measured at Visit 4 (120–180 days postoperatively). Results: Visit 4 mean absolute axis misalignment in the All Toric group was 4.68°±7.33°, and all subjects had ≤5° absolute rotation from Visit 3 to Visit 4. The 1.25 D group had significantly greater improvement in dioptric cylinder reduction (P<0.001), percent cylinder reduction (P<0.001), and mean uncorrected distance visual acuity (P<0.001), compared to control at Visit 4. Most adverse events (AEs) were mild, with no serious AEs in the study eyes. The rates of cumulative AEs through Visit 4 were below International Organization for Standardization (ISO) standard 11979-7 AE rates. Conclusion: enVista MX60T Toric IOL is safe and effective for patients with preoperative corneal astigmatism undergoing IOL implantation. Keywords: human, IOL, astigmatism, cataract, enVista, clinicalPacker MWilliams JIFeinerman GHope RSDove Medical PressarticleHumanIOLastigmatismcataractOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 1031-1039 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Human IOL astigmatism cataract Ophthalmology RE1-994
spellingShingle	Human IOL astigmatism cataract Ophthalmology RE1-994 Packer M Williams JI Feinerman G Hope RS Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
description	Mark Packer,1 Jon I Williams,2 Gregg Feinerman,3 Richard S Hope2 On behalf of the enVista Toric Clinical Study Group 1Mark Packer MD Consulting, Inc., Boulder, CO, USA; 2Surgical Clinical and Medical Affairs, Bausch & Lomb Inc., Irvine, CA, USA; 3Feinerman Vision Center, Newport Beach, CA, USA Purpose: Glistening formation in the intraocular lens (IOL) optic has the potential to impact quality of vision. The enVista One-Piece Hydrophobic Acrylic Spherical IOL Model MX60 (MX60 IOL) is currently the only US Food and Drug Administration-approved IOL with a label of “no glistenings”. The purpose of this prospective, multicenter, partially randomized, partially controlled, double-masked, pivotal study was to evaluate the safety and effectiveness of the enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL). Patients and methods: Subjects (n=191) were implanted with the enVista MX60T Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL (control). Eyes within the lowest range of corneal astigmatism were randomized to receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio. All subjects with corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs received toric IOLs. Rotational stability, cylinder reduction, and best-corrected distance visual acuity were primary effectiveness endpoints measured at Visit 4 (120–180 days postoperatively). Results: Visit 4 mean absolute axis misalignment in the All Toric group was 4.68°±7.33°, and all subjects had ≤5° absolute rotation from Visit 3 to Visit 4. The 1.25 D group had significantly greater improvement in dioptric cylinder reduction (P<0.001), percent cylinder reduction (P<0.001), and mean uncorrected distance visual acuity (P<0.001), compared to control at Visit 4. Most adverse events (AEs) were mild, with no serious AEs in the study eyes. The rates of cumulative AEs through Visit 4 were below International Organization for Standardization (ISO) standard 11979-7 AE rates. Conclusion: enVista MX60T Toric IOL is safe and effective for patients with preoperative corneal astigmatism undergoing IOL implantation. Keywords: human, IOL, astigmatism, cataract, enVista, clinical
format	article
author	Packer M Williams JI Feinerman G Hope RS
author_facet	Packer M Williams JI Feinerman G Hope RS
author_sort	Packer M
title	Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
title_short	Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
title_full	Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
title_fullStr	Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
title_full_unstemmed	Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
title_sort	prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/e48349c685804bffb3ed98c90af10cdd
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Prospective multicenter clinical trial to evaluate the safety and effectiveness of a new glistening-free one-piece acrylic toric intraocular lens

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