Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system

Javier Mendicute,1 Thierry Amzallag,2 Lixin Wang,3 Aldo A Martinez4 1Department of Ophthalmology, Hospital Universitario Donostia, San Sebastián, Spain; 2Department of Ophthalmology, Ophthalmic Institute, North of France, Somain, France; 3Ophthalmology Unit, Novartis Pharmaceuticals Corp...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Mendicute J, Amzallag T, Wang L, Martinez AA
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	Corneal incision Intraocular lens Preloaded IOL injector UltraSert Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/a4ae8196ee1842c9831313e39fe9e3d7
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:a4ae8196ee1842c9831313e39fe9e3d7
record_format	dspace
spelling	oai:doaj.org-article:a4ae8196ee1842c9831313e39fe9e3d72021-12-02T06:19:41ZComparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system1177-5483https://doaj.org/article/a4ae8196ee1842c9831313e39fe9e3d72018-08-01T00:00:00Zhttps://www.dovepress.com/comparison-of-incision-size-and-intraocular-lens-performance-after-imp-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Javier Mendicute,1 Thierry Amzallag,2 Lixin Wang,3 Aldo A Martinez4 1Department of Ophthalmology, Hospital Universitario Donostia, San Sebastián, Spain; 2Department of Ophthalmology, Ophthalmic Institute, North of France, Somain, France; 3Ophthalmology Unit, Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA; 4Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA Purpose: To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System). Setting: Six study sites (four in Spain and two in France). Design: Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. Materials and methods: Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit. Results: One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]). Conclusion: Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system. Keywords: corneal incision, intraocular lens, preloaded IOL injector, UltraSertMendicute JAmzallag TWang LMartinez AADove Medical PressarticleCorneal incision Intraocular lens Preloaded IOL injector UltraSertOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 12, Pp 1495-1503 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Corneal incision Intraocular lens Preloaded IOL injector UltraSert Ophthalmology RE1-994
spellingShingle	Corneal incision Intraocular lens Preloaded IOL injector UltraSert Ophthalmology RE1-994 Mendicute J Amzallag T Wang L Martinez AA Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
description	Javier Mendicute,1 Thierry Amzallag,2 Lixin Wang,3 Aldo A Martinez4 1Department of Ophthalmology, Hospital Universitario Donostia, San Sebastián, Spain; 2Department of Ophthalmology, Ophthalmic Institute, North of France, Somain, France; 3Ophthalmology Unit, Novartis Pharmaceuticals Corporation, Fort Worth, TX, USA; 4Medical Affairs, Alcon Laboratories, Inc., Fort Worth, TX, USA Purpose: To compare corneal incision size and intraocular lens (IOL) performance/behavior following implantation with the following delivery systems: system U (UltraSert®), system S (Hoya iSert® 250/251), system T (Tecnis® iTec), and a manual system (Monarch® III Delivery System). Setting: Six study sites (four in Spain and two in France). Design: Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. Materials and methods: Subjects were enrolled based on predetermined inclusion/exclusion criteria. The effectiveness end points compared corneal incision size and enlargement after IOL implantation (day of surgery) among all delivery systems. Exploratory end points included mean enlargement of corneal incision size, rates of trapped trailing haptic, IOL adherence to the plunger tip, nozzle tip splitting, and mean surgically induced astigmatism (SIA) at postoperative visit. Results: One hundred and nine subjects participated in the study. The mean corneal incision size following IOL implantation was 2.35±0.019 mm for system U, 2.47±0.016 mm for system T, 2.54±0.019 mm for system S, and 2.49±0.011 mm for the manual system. There were five instances of trapped trailing haptic (all system T group, N=26), one instance of IOL adherence to the plunger tip (system S group, N=26), and six instances of nozzle tip splitting (all system S group, N=26). System U had the least SIA (postoperative Day 1) (SIA Centroid = 0.10 diopters [axis: 83.06°]). Conclusion: Preloaded delivery system U supported the completion of surgery with the smallest incision size, the least SIA (postoperative Day 1), and no trapped trailing haptics or nozzle tip splitting compared to two other preloaded systems and one manual system. Keywords: corneal incision, intraocular lens, preloaded IOL injector, UltraSert
format	article
author	Mendicute J Amzallag T Wang L Martinez AA
author_facet	Mendicute J Amzallag T Wang L Martinez AA
author_sort	Mendicute J
title	Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
title_short	Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
title_full	Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
title_fullStr	Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
title_full_unstemmed	Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
title_sort	comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/a4ae8196ee1842c9831313e39fe9e3d7
work_keys_str_mv	AT mendicutej comparisonofincisionsizeandintraocularlensperformanceafterimplantationwiththreepreloadedsystemsandonemanualdeliverysystem AT amzallagt comparisonofincisionsizeandintraocularlensperformanceafterimplantationwiththreepreloadedsystemsandonemanualdeliverysystem AT wangl comparisonofincisionsizeandintraocularlensperformanceafterimplantationwiththreepreloadedsystemsandonemanualdeliverysystem AT martinezaa comparisonofincisionsizeandintraocularlensperformanceafterimplantationwiththreepreloadedsystemsandonemanualdeliverysystem
_version_	1718399954515394560

Comparison of incision size and intraocular lens performance after implantation with three preloaded systems and one manual delivery system

Ejemplares similares