title: Clinical evaluation of the Unfolder.
abstract: OBJECTIVE
  To evaluate the clinical acceptability of the Unfolder for implantation of AMO PhacoFlex II (model SI-30NB or SI-40NB) intraocular lenses (IOLs).
  
  
  METHODS
  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.
authors.forename: R
authors.initials: R
authors.lastname: Olson
authors.forename: R
authors.initials: R
authors.lastname: Cameron
authors.forename: T
authors.initials: T
authors.lastname: Hovis
authors.forename: J
authors.initials: J
authors.lastname: Hunkeler
authors.forename: R
authors.initials: R
authors.lastname: Lindstrom
authors.forename: R
authors.initials: R
authors.lastname: Steinert
mesh_terms: D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000295:instrumentation*; D007910:Lenses, Intraocular; D008875:Middle Aged; D018918:Phacoemulsification; D019904:Polymethyl Methacrylate; D011126:Polypropylenes; D012449:Safety; D013536:Suture Techniques; D014481:United States
chemical_list: D011126:Polypropylenes; D019904:Polymethyl Methacrylate