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Clinical evaluation of the Unfolder

Identifieur interne : 001483 ( PascalFrancis/Curation ); précédent : 001482; suivant : 001484

Clinical 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 :

RBID : Pascal:98-0039954

Descripteurs français

English descriptors

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.
pA  
A01 01  1    @0 0886-3350
A02 01      @0 JCSUEV
A03   1    @0 J. cataract refractive surg.
A05       @2 23
A06       @2 9
A08 01  1  ENG  @1 Clinical evaluation of the Unfolder
A11 01  1    @1 OLSON (R.)
A11 02  1    @1 CAMERON (R.)
A11 03  1    @1 HOVIS (T.)
A11 04  1    @1 HUNKELER (J.)
A11 05  1    @1 LINDSTROM (R.)
A11 06  1    @1 STEINERT (R.)
A14 01      @1 University of Utah @2 Salt Lake City, Utah @3 USA @Z 1 aut.
A14 02      @1 Abilene Regional Medical Center @2 Abilene, Texas @3 USA @Z 2 aut.
A14 03      @1 Columbus Community Hospital @2 Columbus, Texas @3 USA @Z 3 aut.
A14 04      @1 University of Kansas/Kansas City @2 Kansas City, Missouri @3 USA @Z 4 aut.
A14 05      @1 Phillips Eye Institute @2 Minneapolis, Minnesota @3 USA @Z 5 aut.
A14 06      @1 Harvard Medical School @2 Boston, Massachusetts @3 USA @Z 6 aut.
A20       @1 1384-1389
A21       @1 1997
A23 01      @0 ENG
A43 01      @1 INIST @2 20937 @5 354000079687470160
A44       @0 0000 @1 © 1998 INIST-CNRS. All rights reserved.
A45       @0 5 ref.
A47 01  1    @0 98-0039954
A60       @1 P
A61       @0 A
A64   1    @0 Journal of cataract and refractive surgery
A66 01      @0 USA
C01 01    ENG  @0 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.
C02 01  X    @0 002B25B
C03 01  X  FRE  @0 Lentille intraoculaire @5 01
C03 01  X  ENG  @0 Intraocular lens @5 01
C03 01  X  SPA  @0 Lente intraocular @5 01
C03 02  X  FRE  @0 Implantation @5 02
C03 02  X  ENG  @0 Implantation @5 02
C03 02  X  SPA  @0 Implantación @5 02
C03 03  X  FRE  @0 Technique @5 03
C03 03  X  ENG  @0 Technique @5 03
C03 03  X  SPA  @0 Técnica @5 03
C03 04  X  FRE  @0 Appareil @5 04
C03 04  X  ENG  @0 Apparatus @5 04
C03 04  X  SPA  @0 Aparato @5 04
C03 05  X  FRE  @0 Déploiement @5 05
C03 05  X  ENG  @0 Unfolding @5 05
C03 05  X  SPA  @0 Despliegue @5 05
C03 06  X  FRE  @0 Efficacité @5 07
C03 06  X  ENG  @0 Efficiency @5 07
C03 06  X  GER  @0 Wirkungsgrad @5 07
C03 06  X  SPA  @0 Eficacia @5 07
C03 07  X  FRE  @0 Sécurité @5 08
C03 07  X  ENG  @0 Safety @5 08
C03 07  X  GER  @0 Sicherheit @5 08
C03 07  X  SPA  @0 Seguridad @5 08
C03 08  X  FRE  @0 Homme @5 10
C03 08  X  ENG  @0 Human @5 10
C03 08  X  SPA  @0 Hombre @5 10
C07 01  X  FRE  @0 Chirurgie @5 37
C07 01  X  ENG  @0 Surgery @5 37
C07 01  X  SPA  @0 Cirugía @5 37
N21       @1 019

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Pascal:98-0039954

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 (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>
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