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Randomized Controlled Trial
. 2024 May;34(3):766-773.
doi: 10.1177/11206721231204382. Epub 2023 Sep 26.

In vivo comparison of implantation behavior and laboratory analysis of two preloaded intraocular lens injectors

Affiliations
Randomized Controlled Trial

In vivo comparison of implantation behavior and laboratory analysis of two preloaded intraocular lens injectors

Isabella D Baur et al. Eur J Ophthalmol. 2024 May.

Abstract

Purpose: We evaluated implantation behavior and injector damage of two different IOL injector systems, the Multisert and the AutonoMe.

Design: Prospective, randomized, comparative study with laboratory investigation.

Methods: We examined used injectors from 48 bilateral cataract cases and assessed video recordings of each Implantation. All eyes were intraindividually randomized for treatment with one of the two IOL injectors. Implantation videos were reviewed for inadvertent events and the time for different implantation steps was determined. The injector nozzle tips were examined using light and scanning electron microscopy (SEM). Damage was graded using the Heidelberg Score for IOL injector damage (HeiScore). Three months postoperatively, IOLs were assessed for material changes.

Results: Implantation was without critical events in 96 of 96 eyes. Mean implantation time was 41.90 ± 7.11 s with the Multisert and 52.22 ± 12.06 s with the AutonoMe. In the AutonoMe group, we observed 4 eyes (8.3%) with a failed docking attempt, 28 eyes (58.3%) with a haptic adherence, one case (2.1%) of straight leading haptic and 2 cases (4.2%) of intrawound IOL manipulation. There were no events observed in the Multisert group. The mean HeiScore values were 0.87 ± 0.61 and 3.68 ± 0.47 for the AutonoMe and Multisert. 3 months postoperatively, IOL material changes were absent.

Conclusions: Both injectors allowed safe and controlled implantation. Using Multisert, implantation behavior was more consistent. The injectors showed different damage profiles with a higher damage score for the Multisert.The study is registered at the German Clinical Trials Register (Deutsches Register Klinischer Studien; reference number: DRKS00007837).

Keywords: IOLs < LENS / CATARACT; LENS / CATARACT; Surgical instruments / special techniques < LENS / CATARACT; clinical tests < LENS / CATARACT; intraoperative complications of cataract surgery < LENS / CATARACT.

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Figures

Figure 1.
Figure 1.
Representative images of injector damage for different damage profiles. The top row shows examples for the Multisert and the bottom row for the AutonoMe. (a) (b) Examples for injector damage classified as ‘extension’. (c) Example for injector damage classified as ‘crack’. (d) No damage. (e) Example for injectors classified as ‘slight scratches/slight deformation’. (f) Example for injector damage classified as deep scratches/moderate deformation’.
Figure 2.
Figure 2.
Time of IOL implantation. The implantation time was longer for the AutonoMe injector, which was mostly due to a slower IOL unfolding. * Statistically significant difference.
Figure 3.
Figure 3.
Percentage of systems showing inadvertent events during IOL injection for both injectors.
Figure 4.
Figure 4.
The distribution of injector damage profiles for both injectors.

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