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IOL delivery performance of three IOL preloaded delivery systems

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Session Details

Session Title: Pseudophakic IOLs: Monofocal. Cataract Surgery Instrumentation

Session Date/Time: Saturday 05/09/2015 | 16:00-18:30

Paper Time: 17:30

Venue: Room 10

First Author: : L.Wang USA

Co Author(s): :    P. Wolfe   A. Chernosky   S. Paliwal              

Abstract Details

Purpose:

Advancements in cataract surgery have necessitated availability of intraocular lens (IOL) preloaded delivery systems that can safely, effectively and predictably deliver IOLs in the eye. Preloaded delivery systems simplify and reduce procedural variability during surgery preparation. However, if not well-designed, they may yield suboptimal surgical outcomes. Using an ex-vivo porcine eye model, this study evaluated the delivery performance of a new preloaded, disposable, single-handed-use, plunger-driven IOL delivery system with depth-guard nozzle tip design (referred to as “System-AL”). Additionally, the delivery performance of System-AL was compared with two commercially-available preloaded delivery systems – HOYA iSert® 255 (iSert) and TECNIS iTec (iTec).

Setting:

Experimental study conducted at Alcon Laboratories, Fort Worth, Texas, USA

Methods:

Freshly-excised porcine eyes were randomly assigned to four study groups (N=10 per group) consisting of System-AL (2.2mm incision), iSert (2.2mm incision) and iTec (2.2mm and 2.4mm incision) delivering a 21.0D IOL in the capsular bag. IOL delivery parameters were assessed by a single surgeon by measuring pre/post-delivery corneal incision size, rate of successful in-the-bag IOL delivery, and other IOL/delivery system parameters, including IOL adherence to the plunger tip and nozzle tip splitting during IOL delivery. Statistical analysis using Fisher's Exact Test and One-way ANOVA was conducted to determine significance of differences between the study groups.

Results:

System-AL had the least corneal wound enlargement (0.07±0.05mm) and the lowest final incision size (2.31±0.06mm) among all study groups (p less than 0.05). An associated split in the nozzle tip was observed for all iSert devices (no tip splitting was observed for System-AL and iTec; p less than 0.05). Furthermore, in over 50% deliveries with iTec, the IOL remained adhered to the plunger tip after exiting the nozzle (none for System-AL and iSert; p less than 0.05), requiring additional surgical manipulation to release the IOL into the bag. iTec and iSert had 1 occurrence (per study group) of trapped trailing haptic during IOL delivery.

Conclusions:

All delivery systems evaluated in this study successfully placed the IOL in the capsule bag. System-AL had the least corneal wound enlargement and lowest final incision size among all of the preloaded systems tested in this study. The low wound enlargement may be attributed to its depth-guard tip design, no occurrence of nozzle tip split, and uneventful IOL delivery requiring no additional surgical intervention (such as those required for iTec and iSert during occurrences of IOL-to-plunger tip adherence and trapped trailing haptic).

Financial Interest:

One of the authors is employed by a for-profit company with an interest in the subject of the presentation

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