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Clinical evaluation of the Unfolder

Identifieur interne : 002257 ( Istex/Corpus ); précédent : 002256; suivant : 002258

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

Links to Exploration step

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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<ce:copyright type="society" year="1997">American Society of Cataract and Refractive Surgery and European Society of Cataract and Refractive Surgeons. All rights reserved</ce:copyright>
<ce:copyright-line>Copyright 1997 American Society of Cataract and Refractive Surgery and European Society of Cataract and Refractive Surgeons. All rights reserved</ce:copyright-line>
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<ce:article-footnote>
<ce:note-para id="ntp005">Presented in part at the 1997 Royal Hawaiian Eye, Honolulu, Hawaii, USA, January 1997, and the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, April 1997.</ce:note-para>
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<ce:note-para id="ntp010">Supported in part by Allergan and by a grant from Research to Prevent Blindness, Inc., New York, New York, USA, to the Department of Ophthalmology, University of Utah.</ce:note-para>
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<ce:title id="ttl005">Clinical evaluation of the Unfolder</ce:title>
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<ce:author id="AUT005">
<ce:given-name>Randall</ce:given-name>
<ce:surname>Olson</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:sup>a</ce:sup>
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<ce:given-name>Robert</ce:given-name>
<ce:surname>Cameron</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:given-name>Todd</ce:given-name>
<ce:surname>Hovis</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:given-name>John</ce:given-name>
<ce:surname>Hunkeler</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:given-name>Richard</ce:given-name>
<ce:surname>Lindstrom</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:given-name>Roger</ce:given-name>
<ce:surname>Steinert</ce:surname>
<ce:degrees>MD</ce:degrees>
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<ce:text>Reprint requests to Randall Olson, MD, SO North Medical Drive, Salt Lake City, Utah 84132, USA.</ce:text>
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<ce:bold>Purpose:</ce:bold>
To evaluate the clinical acceptability of the Unfolder™ for implantation of AMO® PhacoFlex II® (model SI-30NB or SI-40NB) intraocular lenses (IOLs).</ce:simple-para>
<ce:simple-para id="SP0010">
<ce:bold>Setting:</ce:bold>
Six investigational sites in five states in the United States: Utah, Texas, Missouri, Minnesota, and Massachusetts.</ce:simple-para>
<ce:simple-para id="SP0015">
<ce:bold>Methods:</ce:bold>
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.</ce:simple-para>
<ce:simple-para id="SP0020">
<ce:bold>Results:</ce:bold>
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.</ce:simple-para>
<ce:simple-para id="SP0025">
<ce:bold>Conclusions:</ce:bold>
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.</ce:simple-para>
</ce:abstract-sec>
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<ce:bibliography id="R0005">
<ce:section-title id="SET010">References</ce:section-title>
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<title>Clinical evaluation of the Unfolder</title>
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<title>Clinical evaluation of the Unfolder</title>
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<namePart type="given">John</namePart>
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<name type="personal">
<namePart type="given">Richard</namePart>
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<name type="personal">
<namePart type="given">Roger</namePart>
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<copyrightDate encoding="w3cdtf">1997</copyrightDate>
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<abstract 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.</abstract>
<note>Presented in part at the 1997 Royal Hawaiian Eye, Honolulu, Hawaii, USA, January 1997, and the Symposium on Cataract, IOL and Refractive Surgery, Boston, Massachusetts, USA, April 1997.</note>
<note>Supported in part by Allergan and by a grant from Research to Prevent Blindness, Inc., New York, New York, USA, to the Department of Ophthalmology, University of Utah.</note>
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<identifier type="ISSN">0886-3350</identifier>
<identifier type="PII">S0886-3350(97)X8093-9</identifier>
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<caption>vol.</caption>
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<number>9</number>
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<start>1275</start>
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<identifier type="DOI">10.1016/S0886-3350(97)80119-8</identifier>
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<identifier type="ArticleID">80119</identifier>
<accessCondition type="use and reproduction" contentType="">© 1997American Society of Cataract and Refractive Surgery and European Society of Cataract and Refractive Surgeons. All rights reserved</accessCondition>
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