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

Abstract

PurposeTo 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).SettingSix study sites (four in Spain and two in France).DesignProspective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study.Materials and methodsSubjects 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.ResultsOne 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°]).ConclusionPreloaded 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.

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

“…Indeed, cases of trapped trailing haptics (7-19%) and uncontrolled unfolding of the leading haptic (13%) have been reported in currently available preloaded delivery systems. 11,12,15 Therefore, the anticipated reductions in case time for the preloaded IOL delivery system in the current study may be explained by a combination of these factors, suggesting that this system provides efficient and controlled delivery of the IOL while maintaining an acceptable enhanced safety profile during cataract surgery.…”

“…Previous nonclinical and clinical studies evaluating other automated/preloaded IOL delivery systems have also reported similar small incision sizes that ranged from 2.2 to 2.6 mm for most cases. 11,18,[20][21][22][23][24] The use of smaller incision sizes may be beneficial during IOL implantation as they can promote faster wound healing and reduce the risk of astigmatism, inflammation, and postoperative endophthalmitis. 2,[25][26][27] In the current study, surgeons reported an estimated mean time-savings per procedure of approximately 1 min when compared with other non-preloaded delivery systems.…”

“…These disposable systems can provide a convenient, safe, and simple means of delivering a flexible IOL by simplifying and standardizing the preparation of the IOL for implantation. Although disposable preloaded systems have the potential to reduce loading errors that can lead to surgical complications, preloaded delivery systems have been associated with trapped trailing haptics during delivery into the capsular bag, [11][12][13][14] as well as unfolding of the leading haptic during delivery. 15 The UNFOLDER Vitan Handpiece (Model DK7799; Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) was designed to provide a convenient, safe means of delivering a flexible IOL by simplifying and standardizing the lens preparation for implantation.…”

“…These disposable systems can provide a convenient, safe, and simple means of delivering a flexible IOL by simplifying and standardizing the preparation of the IOL for implantation. Although disposable preloaded systems have the potential to reduce loading errors that can lead to surgical complications, preloaded delivery systems have been associated with trapped trailing haptics during delivery into the capsular bag, 11 – 14 as well as unfolding of the leading haptic during delivery. 15 …”

Sicherheit geht vor – Evaluation von IOL-Injektorsystemen

“…Seit einigen Jahren gibt es neben den manuell zu beladenden Injektoren auch sogenannte Preloaded-Systeme. Durch das Entfallen der manuellen Beladung sollen Risiken wie falsches Einlegen, Faltung oder Beschädigung während der Vorbereitung verhindert werden [1]. Eine mögliche Kontamination durch Berührung im OP-Umfeld wird ausgeschlossen.…”