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In-vitro assessment of the delivery performance of a new IOL preloaded delivery system

Poster Details

First Author: L.Wang USA

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

Abstract Details

Purpose:

With continual advances in modern cataract surgery, development of safe, effective, and predictable mechanisms of intraocular lens (IOL) delivery remains a constant challenge. Preloaded IOL delivery systems provide significant benefits by reducing IOL loading variability, loading error, potential IOL damage and surgical complexity. This laboratory study evaluated the delivery performance of a new preloaded, disposable, single-handed-use, plunger-driven IOL delivery system with depth-guard nozzle tip design (hereinafter referred to as “System-AL”), and compared it with a commercially-available manual-loading IOL delivery system – MONARCH® III with MONARCH® III D cartridge (hereinafter referred to as ‘MONARCH® III’).

Setting:

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

Methods:

Freshly-excised porcine eyes were randomly assigned to two study groups (N=10 per group) consisting of System-AL (2.2mm incision) and MONARCH® III (2.4mm incision) systems delivering a 21.0D IOL into 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/device 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:

Although both System-AL and MONARCH® III delivery system had different initial corneal incision size (knife size of 2.2 and 2.4mm respectively), both the devices yielded comparable corneal wound enlargement of 0.07±0.05mm. Microscopy images of the nozzle lumen after IOL delivery revealed no tip splitting for both devices. Furthermore, System-AL placed the IOL in the capsular bag without requiring additional surgical interventions (such as freeing an adhered IOL from plunger or trapped trailing haptics). IOL optic and haptic unfolding times, measured after IOL delivery into the capsular bag, were comparable for both the devices.

Conclusions:

In conclusion, despite significant differences in the delivery mechanism of System-AL and MONARCH® III (preloaded vs. manual loading) and their respective nozzle tip design (depth-guard vs. straight tip), the System-AL provided IOL delivery performance comparable to a standard-of-care IOL delivery system (MONARCH® III).

Financial Disclosure:

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

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