Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery

Daniel Black,1 Dean Corbett,2 Timothy V Roberts,3,4 Brendan Cronin,5 Pamela J Smith,6 D Priya Janakiraman,6 Beth E Jackson6 1Sunshine Eye Clinic, Birtinya, Queensland, Australia; 2Auckland Eye Ltd, Auckland, New Zealand; 3Sydney Medical School, The University of Sydney, Sydney, New South Wales, Aust...

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Autores principales:	Black D, Corbett D, Roberts TV, Cronin B, Smith PJ, Janakiraman DP, Jackson BE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	cataract surgery iol preloaded delivery system clinical handleability Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/a5b4322250ae4ab3b7b87a0f7309ce9d
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spelling	oai:doaj.org-article:a5b4322250ae4ab3b7b87a0f7309ce9d2021-12-02T12:50:32ZClinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery1177-5483https://doaj.org/article/a5b4322250ae4ab3b7b87a0f7309ce9d2020-08-01T00:00:00Zhttps://www.dovepress.com/clinical-evaluation-of-a-novel-preloaded-intraocular-lens-delivery-sys-peer-reviewed-article-OPTHhttps://doaj.org/toc/1177-5483Daniel Black,1 Dean Corbett,2 Timothy V Roberts,3,4 Brendan Cronin,5 Pamela J Smith,6 D Priya Janakiraman,6 Beth E Jackson6 1Sunshine Eye Clinic, Birtinya, Queensland, Australia; 2Auckland Eye Ltd, Auckland, New Zealand; 3Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia; 4Vision Eye Institute, Sydney, New South Wales, Australia; 5Queensland Eye Institute, South Brisbane, Queensland, Australia; 6Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USACorrespondence: Daniel Black Tel +61 7 5413-8000Fax +61 7 5413-8080Email daniel.black@suneye.com.auPurpose: To evaluate the clinical handleability and acceptability of a novel preloaded intraocular lens (IOL) delivery system for implantation of the TECNIS ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) during routine small-incision cataract surgery.Subjects and Methods: In this prospective, open-label, noncomparative, unilateral or bilateral, multicenter study, adult subjects with unilateral or bilateral cataracts scheduled for IOL implantation were enrolled. Surgeons and surgical technicians completed per-eye day-of-surgery and end-of-surgical-day questionnaires. The primary endpoint of the study was the rate of acceptable overall clinical performance of the preloaded IOL delivery system. Other endpoints included additional responses from the questionnaires, preimplantation incision size, and safety.Results: The study included 91 eyes that underwent cataract surgery and IOL implantation using the preloaded delivery system and were available for the 1-day postoperative visit. Five surgeons and 14 surgical technicians from four investigational sites participated in the study. The rate of acceptable overall clinical performance was 100% (91/91) of eyes, with most responses (78/91; 85.7%) being the highest possible rating of 5 (very satisfied). Favorable responses by most surgeons and surgical technicians regarding additional endpoints further highlighted the handleability and acceptability of the preloaded delivery system. No ocular adverse events or lens findings (ie, no cases of IOL instability, haptic breakage, IOL marking, or crimping) were reported.Conclusion: The results of this study demonstrated that this preloaded IOL delivery system was safe and effective during routine small-incision cataract surgery.Trial Registration: German Clinical Trials Register identifier, DRKS00014757.Keywords: cataract surgery, IOL, preloaded delivery system, clinical handleabilityBlack DCorbett DRoberts TVCronin BSmith PJJanakiraman DPJackson BEDove Medical Pressarticlecataract surgeryiolpreloaded delivery systemclinical handleabilityOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 14, Pp 2291-2300 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	cataract surgery iol preloaded delivery system clinical handleability Ophthalmology RE1-994
spellingShingle	cataract surgery iol preloaded delivery system clinical handleability Ophthalmology RE1-994 Black D Corbett D Roberts TV Cronin B Smith PJ Janakiraman DP Jackson BE Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
description	Daniel Black,1 Dean Corbett,2 Timothy V Roberts,3,4 Brendan Cronin,5 Pamela J Smith,6 D Priya Janakiraman,6 Beth E Jackson6 1Sunshine Eye Clinic, Birtinya, Queensland, Australia; 2Auckland Eye Ltd, Auckland, New Zealand; 3Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia; 4Vision Eye Institute, Sydney, New South Wales, Australia; 5Queensland Eye Institute, South Brisbane, Queensland, Australia; 6Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USACorrespondence: Daniel Black Tel +61 7 5413-8000Fax +61 7 5413-8080Email daniel.black@suneye.com.auPurpose: To evaluate the clinical handleability and acceptability of a novel preloaded intraocular lens (IOL) delivery system for implantation of the TECNIS ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) during routine small-incision cataract surgery.Subjects and Methods: In this prospective, open-label, noncomparative, unilateral or bilateral, multicenter study, adult subjects with unilateral or bilateral cataracts scheduled for IOL implantation were enrolled. Surgeons and surgical technicians completed per-eye day-of-surgery and end-of-surgical-day questionnaires. The primary endpoint of the study was the rate of acceptable overall clinical performance of the preloaded IOL delivery system. Other endpoints included additional responses from the questionnaires, preimplantation incision size, and safety.Results: The study included 91 eyes that underwent cataract surgery and IOL implantation using the preloaded delivery system and were available for the 1-day postoperative visit. Five surgeons and 14 surgical technicians from four investigational sites participated in the study. The rate of acceptable overall clinical performance was 100% (91/91) of eyes, with most responses (78/91; 85.7%) being the highest possible rating of 5 (very satisfied). Favorable responses by most surgeons and surgical technicians regarding additional endpoints further highlighted the handleability and acceptability of the preloaded delivery system. No ocular adverse events or lens findings (ie, no cases of IOL instability, haptic breakage, IOL marking, or crimping) were reported.Conclusion: The results of this study demonstrated that this preloaded IOL delivery system was safe and effective during routine small-incision cataract surgery.Trial Registration: German Clinical Trials Register identifier, DRKS00014757.Keywords: cataract surgery, IOL, preloaded delivery system, clinical handleability
format	article
author	Black D Corbett D Roberts TV Cronin B Smith PJ Janakiraman DP Jackson BE
author_facet	Black D Corbett D Roberts TV Cronin B Smith PJ Janakiraman DP Jackson BE
author_sort	Black D
title	Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
title_short	Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
title_full	Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
title_fullStr	Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
title_full_unstemmed	Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery
title_sort	clinical evaluation of a novel preloaded intraocular lens delivery system during routine cataract surgery
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/a5b4322250ae4ab3b7b87a0f7309ce9d
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Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery

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