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

Clinical Ophthalmology
Javier MendicuteAldo A Martinez

Abstract

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). Six study sites (four in Spain and two in France). Prospective, multicenter, parallel-group, randomized, subject-masked, postmarket clinical study. 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. 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 t...Continue Reading

Clinical Trials Mentioned

NCT02826421

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