Clinical evaluation of the Unfolder
Identifieur interne : 001437 ( PascalFrancis/Checkpoint ); précédent : 001436; suivant : 001438Clinical evaluation of the Unfolder
Auteurs : R. Olson [États-Unis] ; R. Cameron [États-Unis] ; T. Hovis [États-Unis] ; J. Hunkeler [États-Unis] ; R. Lindstrom [États-Unis] ; R. Steinert [États-Unis]Source :
- Journal of cataract and refractive surgery [ 0886-3350 ] ; 1997.
Descripteurs français
- Pascal (Inist)
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- topic : Homme.
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Abstract
Purpose: To evaluate the clinical acceptability of the Unfolder for implantation of AMO® PhacoFlex II® (model SI-30NB or SI-40NB) intraocular lenses (lOLs). 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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Clinical evaluation of the Unfolder</title><author><name sortKey="Olson, R" sort="Olson, R" uniqKey="Olson R" first="R." last="Olson">R. Olson</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Utah</s1><s2>Salt Lake City, Utah</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Utah</region></placeName></affiliation></author><author><name sortKey="Cameron, R" sort="Cameron, R" uniqKey="Cameron R" first="R." last="Cameron">R. Cameron</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Abilene Regional Medical Center</s1><s2>Abilene, Texas</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Hovis, T" sort="Hovis, T" uniqKey="Hovis T" first="T." last="Hovis">T. Hovis</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Columbus Community Hospital</s1><s2>Columbus, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Hunkeler, J" sort="Hunkeler, J" uniqKey="Hunkeler J" first="J." last="Hunkeler">J. Hunkeler</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>University of Kansas/Kansas City</s1><s2>Kansas City, Missouri</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Missouri (État)</region></placeName></affiliation></author><author><name sortKey="Lindstrom, R" sort="Lindstrom, R" uniqKey="Lindstrom R" first="R." last="Lindstrom">R. Lindstrom</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Phillips Eye Institute</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Steinert, R" sort="Steinert, R" uniqKey="Steinert R" first="R." last="Steinert">R. Steinert</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Harvard Medical School</s1><s2>Boston, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">98-0039954</idno><date when="1997">1997</date><idno type="stanalyst">PASCAL 98-0039954 INIST</idno><idno type="RBID">Pascal:98-0039954</idno><idno type="wicri:Area/PascalFrancis/Corpus">001637</idno><idno type="wicri:Area/PascalFrancis/Curation">001483</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001437</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Clinical evaluation of the Unfolder</title><author><name sortKey="Olson, R" sort="Olson, R" uniqKey="Olson R" first="R." last="Olson">R. Olson</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>University of Utah</s1><s2>Salt Lake City, Utah</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Utah</region></placeName></affiliation></author><author><name sortKey="Cameron, R" sort="Cameron, R" uniqKey="Cameron R" first="R." last="Cameron">R. Cameron</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Abilene Regional Medical Center</s1><s2>Abilene, Texas</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Hovis, T" sort="Hovis, T" uniqKey="Hovis T" first="T." last="Hovis">T. Hovis</name><affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Columbus Community Hospital</s1><s2>Columbus, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Hunkeler, J" sort="Hunkeler, J" uniqKey="Hunkeler J" first="J." last="Hunkeler">J. Hunkeler</name><affiliation wicri:level="2"><inist:fA14 i1="04"><s1>University of Kansas/Kansas City</s1><s2>Kansas City, Missouri</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Missouri (État)</region></placeName></affiliation></author><author><name sortKey="Lindstrom, R" sort="Lindstrom, R" uniqKey="Lindstrom R" first="R." last="Lindstrom">R. Lindstrom</name><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Phillips Eye Institute</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Steinert, R" sort="Steinert, R" uniqKey="Steinert R" first="R." last="Steinert">R. Steinert</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Harvard Medical School</s1><s2>Boston, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Journal of cataract and refractive surgery</title><title level="j" type="abbreviated">J. cataract refractive surg.</title><idno type="ISSN">0886-3350</idno><imprint><date when="1997">1997</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of cataract and refractive surgery</title><title level="j" type="abbreviated">J. cataract refractive surg.</title><idno type="ISSN">0886-3350</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Apparatus</term><term>Efficiency</term><term>Human</term><term>Implantation</term><term>Intraocular lens</term><term>Safety</term><term>Technique</term><term>Unfolding</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Lentille intraoculaire</term><term>Implantation</term><term>Technique</term><term>Appareil</term><term>Déploiement</term><term>Efficacité</term><term>Sécurité</term><term>Homme</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><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 (lOLs). 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></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0886-3350</s0></fA01><fA02 i1="01"><s0>JCSUEV</s0></fA02><fA03 i2="1"><s0>J. cataract refractive surg.</s0></fA03><fA05><s2>23</s2></fA05><fA06><s2>9</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Clinical evaluation of the Unfolder</s1></fA08><fA11 i1="01" i2="1"><s1>OLSON (R.)</s1></fA11><fA11 i1="02" i2="1"><s1>CAMERON (R.)</s1></fA11><fA11 i1="03" i2="1"><s1>HOVIS (T.)</s1></fA11><fA11 i1="04" i2="1"><s1>HUNKELER (J.)</s1></fA11><fA11 i1="05" i2="1"><s1>LINDSTROM (R.)</s1></fA11><fA11 i1="06" i2="1"><s1>STEINERT (R.)</s1></fA11><fA14 i1="01"><s1>University of Utah</s1><s2>Salt Lake City, Utah</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Abilene Regional Medical Center</s1><s2>Abilene, Texas</s2><s3>USA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Columbus Community Hospital</s1><s2>Columbus, Texas</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>University of Kansas/Kansas City</s1><s2>Kansas City, Missouri</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Phillips Eye Institute</s1><s2>Minneapolis, Minnesota</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Harvard Medical School</s1><s2>Boston, Massachusetts</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><fA20><s1>1384-1389</s1></fA20><fA21><s1>1997</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20937</s2><s5>354000079687470160</s5></fA43><fA44><s0>0000</s0><s1>© 1998 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>5 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>98-0039954</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i2="1"><s0>Journal of cataract and refractive surgery</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose: To evaluate the clinical acceptability of the Unfolder for implantation of AMO® PhacoFlex II® (model SI-30NB or SI-40NB) intraocular lenses (lOLs). 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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B25B</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Lentille intraoculaire</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Intraocular lens</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Lente intraocular</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Implantation</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Implantation</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Implantación</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Technique</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Technique</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Técnica</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Appareil</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Apparatus</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Aparato</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Déploiement</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Unfolding</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Despliegue</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Efficacité</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Efficiency</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="GER"><s0>Wirkungsgrad</s0><s5>07</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Eficacia</s0><s5>07</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Sécurité</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Safety</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="GER"><s0>Sicherheit</s0><s5>08</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Seguridad</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0><s5>10</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Human</s0><s5>10</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0><s5>10</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Chirurgie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Surgery</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Cirugía</s0><s5>37</s5></fC07><fN21><s1>019</s1></fN21></pA></standard></inist><affiliations><list><country><li>États-Unis</li></country><region><li>Massachusetts</li><li>Minnesota</li><li>Missouri (État)</li><li>Texas</li><li>Utah</li></region></list><tree><country name="États-Unis"><region name="Utah"><name sortKey="Olson, R" sort="Olson, R" uniqKey="Olson R" first="R." last="Olson">R. Olson</name></region><name sortKey="Cameron, R" sort="Cameron, R" uniqKey="Cameron R" first="R." last="Cameron">R. Cameron</name><name sortKey="Hovis, T" sort="Hovis, T" uniqKey="Hovis T" first="T." last="Hovis">T. Hovis</name><name sortKey="Hunkeler, J" sort="Hunkeler, J" uniqKey="Hunkeler J" first="J." last="Hunkeler">J. Hunkeler</name><name sortKey="Lindstrom, R" sort="Lindstrom, R" uniqKey="Lindstrom R" first="R." last="Lindstrom">R. Lindstrom</name><name sortKey="Steinert, R" sort="Steinert, R" uniqKey="Steinert R" first="R." last="Steinert">R. Steinert</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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