Comparative evaluation of corneal incision enlargement after intraocular lens delivery of new preloaded and manual implantation systems.

PURPOSE: To determine whether total corneal incision enlargement after implantation of an intraocular lens with a new preloaded delivery system is comparable to a standard-of-care manual delivery system using an in vitro human cadaver eye model, despite having a smaller initial incision size. METHODS: Human cadaver phakic whole eye globes were used for these studies (n = 16 per group). Each pair of eyes was randomly assigned to a new preloaded delivery system (UltraSertTM) or a manual delivery system (MONARCH® III D). The surgical procedure included creating a 2.2- and 2.4-mm corneal incision for the preloaded and manual delivery systems, respectively, measuring intraocular pressure and pre-implantation corneal incision size, delivering the intraocular lens into the anterior chamber, and measuring the post-implantation incision size. RESULTS: The final corneal incision enlargement after intraocular lens delivery using the preloaded delivery system was 2.33 ± 0.04 mm, compared to 2.54 ± 0.05 mm after intraocular lens delivery with the manual delivery system. The mean corneal incision enlargement was comparable between the two systems, being 0.13 ± 0.04 mm using the preloaded delivery system and 0.14 ± 0.05 mm using the manual delivery system (p = 0.432). CONCLUSION: In a human cadaver eye model, the preloaded delivery system demonstrated an intraocular lens delivery performance on cornea incision enlargement was noninferior to the manual, standard-of-care intraocular lens delivery system despite a smaller initial incision size. TRANSLATIONAL RELEVANCE: Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.

In vitro delivery performance assessment of a new preloaded intraocular lens delivery system.

PURPOSE: To compare the delivery performance of a new preloaded intraocular lens (IOL) delivery system (Ultrasert [system U]) with that of 2 commercially available preloaded systems (iSert [system S] and Tecnis iTec [system T]), and a manual system (Monarch III D). SETTING: Alcon Laboratories, Fort Worth, Texas, USA. DESIGN: Experimental study. METHODS: Freshly excised porcine eyes were randomly assigned to 5 groups of 10 eyes each as follows: preloaded systems U, S, T 2.2 mm incision, T 2.4 mm incision, and manual system. Corneal incision size was measured before and after delivery. The rate of successful in-the-bag IOL delivery, IOL adherence to the plunger tip, trapped trailing haptic, and presence of nozzle tip splitting were assessed. Statistical analysis was performed to determine the significance of differences between groups. RESULTS: All systems successfully placed the IOL in the capsular bag. System U had the least corneal incision enlargement (mean 0.07 mm ± 0.05 [SD]) and the smallest final incision size (mean 2.31 ± 0.06 mm) (P < .05). An associated split in the nozzle tip was observed for system S devices (P < .05). Furthermore, in more than 50% of deliveries with system T, the IOL remained adhered to the plunger tip after exiting the nozzle (P < .05). Systems S and T each had 1 occurrence of a trapped trailing haptic during IOL delivery. CONCLUSION: The new design of the system U with a depth-guard nozzle tip allowed for the smallest incision enlargement with an absence of nozzle tip splitting and uneventful IOL delivery compared with the other preloaded systems tested in this study. FINANCIAL DISCLOSURE: Drs. Tjia and Lane are consultants to Alcon Laboratories, Inc. Drs. Wang, Wolfe, Paliwal, and Miss Chernosky are employees of Alcon Laboratories, Inc.