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. 2018 Aug 21:12:1495-1503.
doi: 10.2147/OPTH.S166776. eCollection 2018.

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 Martinez  4
Affiliations

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

Javier Mendicute et al. Clin Ophthalmol. .

Abstract

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: UltraSert; corneal incision; intraocular lens; preloaded IOL injector.

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Conflict of interest statement

Disclosure Lixin Wang, MD, PhD, is a full-time employee of Novartis Pharmaceuticals Corporation. Aldo A Martinez, PhD, is a full-time employee of Alcon Laboratories, Inc. Javier Mendicute, MD, PhD, is a consultant for Alcon Laboratories, Inc., and received research support from Alcon Laboratories, Inc., AcuFocus, Inc., MEDICEM, Novagali Pharma S.A., and Carl Zeiss Meditec, Inc. Thierry Amzallag, MD, has received personal fees from Alcon Laboratories, Cutting Edge, and Théa, and is a clinical trial investigator for Zeiss. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
The UltraSert® preloaded delivery system. Notes: The UltraSert preloaded delivery system (Alcon Laboratories, Inc., Fort Worth, TX, USA) is a single-use system made up of a nozzle, main body, and plunger that delivers the preloaded IOL by manually advancing the plunger with a push mechanism. The system is Food and Drug Administration (FDA)-approved for use with the AcrySof® IQ Aspheric IOL (Alcon Laboratories, Inc.) in patients undergoing cataract surgery. Abbreviation: IOL, intraocular lens.
Figure 2
Figure 2
Mean corneal incision size after intraocular lens implantation of preloaded systems or manual delivery system. Notes: (A) Preloaded system U had the smallest mean corneal incision size among the preloaded devices. Preloaded systems T and S resulted in significantly greater mean corneal incision sizes. (B) Preloaded system U resulted in a significantly smaller mean corneal incision size than the manual delivery system. Data presented as mean ± standard error; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system. *Statistical significance (P<0.025), as determined by a two-sample t-test based on superiority hypothesis testing as compared to preloaded system T, system S, or the manual delivery system.
Figure 3
Figure 3
Mean corneal incision size enlargement caused by IOL delivery using preloaded systems or manual delivery system. Notes: (A) Preloaded system U had the least corneal incision enlargement among the preloaded devices. Incision enlargements following IOL insertion using preloaded system T and system S were greater than those of system U. (B) The manual delivery system resulted in less corneal incision enlargement than preloaded system U and had the least mean corneal incision enlargement of all the devices tested. Data presented as mean; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system. Abbreviation: IOL, intraocular lens.
Figure 4
Figure 4
SIA following implantation of preloaded systems or manual delivery system. Notes: (A) Less SIA was observed in patients following intraocular lens insertion using preloaded system U than that of systems T and S. (B) Preloaded system U also resulted in less SIA than the manual delivery system. Data presented as mean; n=19 eyes for preloaded system U, 26 eyes for preloaded system T, 26 eyes for preloaded system S, and 28 eyes for the manual delivery system. Abbreviations: D, diopters; SIA, surgically induced astigmatism.
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