<p>Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery</p>

Abstract

Purpose: 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 smallincision 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.

The impact of preloaded intraocular lens implantation system (TECNIS iTec®) in routine cataract surgery in China: a time-motion analysis

“…The preloaded IOL has been demonstrated for its safety and effectiveness, long-term stability and excellent visual quality [ 6 , 11 , 20 ]. Surgeons and surgical technicians are more satisfied with the use of preloaded IOL, especially for the ease of lens preparation, the number of steps required and the total implantation time [ 20 – 23 ].…”

“…The preloaded IOL has been demonstrated for its safety and effectiveness, long-term stability and excellent visual quality [ 6 , 11 , 20 ]. Surgeons and surgical technicians are more satisfied with the use of preloaded IOL, especially for the ease of lens preparation, the number of steps required and the total implantation time [ 20 – 23 ]. Additionally, the preloaded IOL offers several benefits over reusable, manual IOL, including a reduced chance of IOL damage during loading, shortened surgery time, the need for fewer surgical instruments, lower risk for contamination, and elimination of other manual setting errors, reduced incision size and quicker recovery [ 11 , 20 , 24 ].…”

“…Another study conducted in France and Spain showed that the implantation time of preloaded IOL was similar to that of manual IOL (12.9s vs. 12.2s), but the preparation time of preloaded IOL was shorter than that of manual IOL with a 49.3% reduction (30.3s vs. 59.8s) [ 21 ]. A study conducting in New Zealand and Australia found that the mean estimated time-savings per procedure was 54.9s compared with non-preloaded delivery systems [ 20 ]. The preloaded IOL has the design advantages for elimination of the need for loading IOL into the introducer and combining the introducer with the pusher, which reduced number of preparation steps and improves intraoperative efficiency.…”

Video analysis of optic-haptic-interaction during hydrophobic acrylic intraocular lens implantation using preloaded injectors

“…The move towards preloading injectors was accompanied by improvements in injector design, eliminating the necessity for manual loading of the IOL during the surgical procedure. Consequently, this has reduced procedural variability during IOL preparation and loading, ultimately contributing to a reduction in the overall duration of the surgical procedure [ 2 – 4 ].…”

Clinical Evaluation of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in a Korean Population

“…In contrast with manually loaded IOLs, preloaded delivery systems allow for reduced device preparation time, 9,10 which can significantly shorten total surgical case times and potentially increase efficiency of surgical centers and help meet the increased demand for cataract surgery. 9,[11][12][13] Preloaded delivery systems can also improve the consistency of IOL haptic folding and reduce the risk of IOL damage 9,10,14,15 by eliminating loading variability or user error and reducing the risk of contamination by eliminating the need to handle the IOL. 12,[16][17][18] A prospective, randomized, comparative study reported that the AutonoMe Delivery System provided safe and easy IOL delivery; no haptic misconfigurations were observed.…”