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Clinical evaluation of the Unfolder.

Identifieur interne : 001F90 ( PubMed/Corpus ); précédent : 001F89; suivant : 001F91

Clinical evaluation of the Unfolder.

Auteurs : R. Olson ; R. Cameron ; T. Hovis ; J. Hunkeler ; R. Lindstrom ; R. Steinert

Source :

RBID : pubmed:9423912

English descriptors

Abstract

To evaluate the clinical acceptability of the Unfolder for implantation of AMO PhacoFlex II (model SI-30NB or SI-40NB) intraocular lenses (IOLs).

PubMed: 9423912

Links to Exploration step

pubmed:9423912

Le document en format XML

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<title xml:lang="en">Clinical evaluation of the Unfolder.</title>
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<name sortKey="Olson, R" sort="Olson, R" uniqKey="Olson R" first="R" last="Olson">R. Olson</name>
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<name sortKey="Cameron, R" sort="Cameron, R" uniqKey="Cameron R" first="R" last="Cameron">R. Cameron</name>
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<name sortKey="Hovis, T" sort="Hovis, T" uniqKey="Hovis T" first="T" last="Hovis">T. Hovis</name>
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<name sortKey="Hunkeler, J" sort="Hunkeler, J" uniqKey="Hunkeler J" first="J" last="Hunkeler">J. Hunkeler</name>
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<name sortKey="Lindstrom, R" sort="Lindstrom, R" uniqKey="Lindstrom R" first="R" last="Lindstrom">R. Lindstrom</name>
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<name sortKey="Steinert, R" sort="Steinert, R" uniqKey="Steinert R" first="R" last="Steinert">R. Steinert</name>
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<name sortKey="Cameron, R" sort="Cameron, R" uniqKey="Cameron R" first="R" last="Cameron">R. Cameron</name>
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<name sortKey="Hovis, T" sort="Hovis, T" uniqKey="Hovis T" first="T" last="Hovis">T. Hovis</name>
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<name sortKey="Hunkeler, J" sort="Hunkeler, J" uniqKey="Hunkeler J" first="J" last="Hunkeler">J. Hunkeler</name>
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<term>Evaluation Studies as Topic</term>
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<term>Humans</term>
<term>Lens Implantation, Intraocular (instrumentation)</term>
<term>Lenses, Intraocular</term>
<term>Middle Aged</term>
<term>Phacoemulsification</term>
<term>Polymethyl Methacrylate</term>
<term>Polypropylenes</term>
<term>Safety</term>
<term>Suture Techniques</term>
<term>United States</term>
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<keywords scheme="MESH" type="chemical" xml:lang="en">
<term>Polymethyl Methacrylate</term>
<term>Polypropylenes</term>
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<term>United States</term>
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<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en">
<term>Lens Implantation, Intraocular</term>
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<term>Evaluation Studies as Topic</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Lenses, Intraocular</term>
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<front>
<div type="abstract" xml:lang="en">To evaluate the clinical acceptability of the Unfolder for implantation of AMO PhacoFlex II (model SI-30NB or SI-40NB) intraocular lenses (IOLs).</div>
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<Day>27</Day>
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<Year>1998</Year>
<Month>01</Month>
<Day>27</Day>
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<Year>2007</Year>
<Month>11</Month>
<Day>15</Day>
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<ISSN IssnType="Print">0886-3350</ISSN>
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<Volume>23</Volume>
<Issue>9</Issue>
<PubDate>
<Year>1997</Year>
<Month>Nov</Month>
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<Title>Journal of cataract and refractive surgery</Title>
<ISOAbbreviation>J Cataract Refract Surg</ISOAbbreviation>
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<AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">To evaluate the clinical acceptability of the Unfolder for implantation of AMO PhacoFlex II (model SI-30NB or SI-40NB) intraocular lenses (IOLs).</AbstractText>
<AbstractText Label="SETTING" NlmCategory="METHODS">Six investigational sites in five states in the United States: Utah, Texas, Missouri, Minnesota, and Massachusetts.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
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