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

Autor: Black, Daniel, Corbett, Dean, Roberts, Timothy V, Cronin, Brendan, Smith, Pamela J, Janakiraman, D Priya, Jackson, Beth E
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Clinical Ophthalmology (Auckland, N.Z.)
ISSN: 1177-5483
1177-5467
5413-8000
Popis: 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
Databáze: OpenAIRE
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