CLINICAL-EVALUATION OF THE UNFOLDER

Purpose: To evaluate the clinical acceptability of the Unfolder(TM) fo r implantation of AMO(R) PhacoFlex II (R) (model SI-30NB or SI-40NB) i ntraocular lenses (IOLs). Setting: Six investigational sites in five s lates in the United States: Utah, Texas, Missouri, Minnesota, and Mass achusetts. Methods: One hundred one patients from six investigational sites had implantation of an SI-SONB or SI-40NB IOL. Investigators eva luated the clinical acceptability of the Unfolder by comparing their e xperience 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 wer e collected. Results: The investigators rated the Unfolder as clinical ly acceptable. Mean internal incision size after phacoemulsification b ut before IOL implantation was 3.0 mm +/- 0.1 (SD) (range 2.7 to 3.2 m m). 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 e vents were reported. Conclusions: Investigators found the Unfolder eas y to use. It provided controlled lens implantation through incisions 2 .7 to 3.2 mm, with post-lOl implantation incisions ranging from 2.9 to 3.3 mm.