Clinical evaluation of the Unfolder.
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.
Olson
R
R
Cameron
R
R
Hovis
T
T
Hunkeler
J
J
Lindstrom
R
R
Steinert
R
R
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
D011126:Polypropylenes; D019904:Polymethyl Methacrylate