Clinical evaluation of the Unfolder
Identifieur interne : 008B34 ( Main/Exploration ); précédent : 008B33; suivant : 008B35Clinical evaluation of the Unfolder
Auteurs : Randall Olson ; Robert Cameron ; Todd Hovis ; John Hunkeler ; Richard Lindstrom ; Roger SteinertSource :
- Journal of Cataract & Refractive Surgery [ 0886-3350 ] ; 1997.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : États-Unis.
- topic : Homme.
English descriptors
- KwdEn :
- Apparatus, Efficiency, Evaluation Studies as Topic, Follow-Up Studies, Human, Humans, Implantation, Intraocular lens, Lens Implantation, Intraocular (instrumentation), Lenses, Intraocular, Middle Aged, Phacoemulsification, Polymethyl Methacrylate, Polypropylenes, Safety, Suture Techniques, Technique, Unfolding, United States.
- MESH :
- chemical : Polymethyl Methacrylate, Polypropylenes.
- geographic : United States.
- instrumentation : Lens Implantation, Intraocular.
- Evaluation Studies as Topic, Follow-Up Studies, Humans, Lenses, Intraocular, Middle Aged, Phacoemulsification, Safety, Suture Techniques.
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
Affiliations:
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Le document en format XML
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<author><name sortKey="Hovis, Todd" sort="Hovis, Todd" uniqKey="Hovis T" first="Todd" last="Hovis">Todd Hovis</name>
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<author><name sortKey="Hunkeler, John" sort="Hunkeler, John" uniqKey="Hunkeler J" first="John" last="Hunkeler">John Hunkeler</name>
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<author><name sortKey="Lindstrom, Richard" sort="Lindstrom, Richard" uniqKey="Lindstrom R" first="Richard" last="Lindstrom">Richard Lindstrom</name>
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<author><name sortKey="Steinert, Roger" sort="Steinert, Roger" uniqKey="Steinert R" first="Roger" last="Steinert">Roger Steinert</name>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Apparatus</term>
<term>Efficiency</term>
<term>Evaluation Studies as Topic</term>
<term>Follow-Up Studies</term>
<term>Human</term>
<term>Humans</term>
<term>Implantation</term>
<term>Intraocular lens</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>Technique</term>
<term>Unfolding</term>
<term>United States</term>
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<keywords scheme="MESH" type="chemical" xml:lang="en"><term>Polymethyl Methacrylate</term>
<term>Polypropylenes</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en"><term>Lens Implantation, Intraocular</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Evaluation Studies as Topic</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Lenses, Intraocular</term>
<term>Middle Aged</term>
<term>Phacoemulsification</term>
<term>Safety</term>
<term>Suture Techniques</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Appareil</term>
<term>Déploiement</term>
<term>Efficacité</term>
<term>Homme</term>
<term>Implantation</term>
<term>Lentille intraoculaire</term>
<term>Sécurité</term>
<term>Technique</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term>
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<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 (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>
</front>
</TEI>
<affiliations><list></list>
<tree><noCountry><name sortKey="Cameron, Robert" sort="Cameron, Robert" uniqKey="Cameron R" first="Robert" last="Cameron">Robert Cameron</name>
<name sortKey="Hovis, Todd" sort="Hovis, Todd" uniqKey="Hovis T" first="Todd" last="Hovis">Todd Hovis</name>
<name sortKey="Hunkeler, John" sort="Hunkeler, John" uniqKey="Hunkeler J" first="John" last="Hunkeler">John Hunkeler</name>
<name sortKey="Lindstrom, Richard" sort="Lindstrom, Richard" uniqKey="Lindstrom R" first="Richard" last="Lindstrom">Richard Lindstrom</name>
<name sortKey="Olson, Randall" sort="Olson, Randall" uniqKey="Olson R" first="Randall" last="Olson">Randall Olson</name>
<name sortKey="Steinert, Roger" sort="Steinert, Roger" uniqKey="Steinert R" first="Roger" last="Steinert">Roger Steinert</name>
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