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Clinical evaluation of the Unfolder

Identifieur interne : 009413 ( Main/Merge ); précédent : 009412; suivant : 009414

Clinical evaluation of the Unfolder

Auteurs : Randall Olson ; Robert Cameron ; Todd Hovis ; John Hunkeler ; Richard Lindstrom ; Roger Steinert

Source :

RBID : ISTEX:751C02821F350BE6A7050B7C14932A7B06E1A802

Abstract

Purpose: To evaluate the clinical acceptability of the Unfolder™ for implantation of AMO® PhacoFlex II® (model SI-30NB or SI-40NB) intraocular lenses (IOLs).Setting: Six investigational sites in five states in the United States: Utah, Texas, Missouri, Minnesota, and Massachusetts.Methods: One hundred one patients from six investigational sites had implantation of an SI-30NB or SI-40NB IOL. Investigators evaluated the clinical acceptability of the Unfolder by comparing their experience with the injector with that using other implantation systems. Internal incision size (dimensions) was measured three times during surgery using a calibrated instrument. Data on safety and efficacy were collected.Results: The investigators rated the Unfolder as clinically acceptable. Mean internal incision size after phacoemulsification but before IOL implantation was 3.0 mm ± 0.1 (SD) (range 2.7 to 3.2 mm). Average internal incision size after IOL implantation was 3.1 ± 0.1 mm. There were no reports of haptic deformation, lens optic damage, or postoperative complications related to the Unfolder. No adverse events were reported.Conclusions: Investigators found the Unfolder easy to use. It provided controlled lens implantation through incisions 2.7 to 3.2 mm, with post-IOL implantation incisions ranging from 2.9 to 3.3 mm.

Url:
DOI: 10.1016/S0886-3350(97)80119-8

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ISTEX:751C02821F350BE6A7050B7C14932A7B06E1A802

Le document en format XML

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<div type="abstract" xml:lang="en">Purpose: To evaluate the clinical acceptability of the Unfolder™ for implantation of AMO® PhacoFlex II® (model SI-30NB or SI-40NB) intraocular lenses (IOLs).Setting: Six investigational sites in five states in the United States: Utah, Texas, Missouri, Minnesota, and Massachusetts.Methods: One hundred one patients from six investigational sites had implantation of an SI-30NB or SI-40NB IOL. Investigators evaluated the clinical acceptability of the Unfolder by comparing their experience with the injector with that using other implantation systems. Internal incision size (dimensions) was measured three times during surgery using a calibrated instrument. Data on safety and efficacy were collected.Results: The investigators rated the Unfolder as clinically acceptable. Mean internal incision size after phacoemulsification but before IOL implantation was 3.0 mm ± 0.1 (SD) (range 2.7 to 3.2 mm). Average internal incision size after IOL implantation was 3.1 ± 0.1 mm. There were no reports of haptic deformation, lens optic damage, or postoperative complications related to the Unfolder. No adverse events were reported.Conclusions: Investigators found the Unfolder easy to use. It provided controlled lens implantation through incisions 2.7 to 3.2 mm, with post-IOL implantation incisions ranging from 2.9 to 3.3 mm.</div>
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