[Clinical 12-month outcome with the foldable, hydrophobic acrylic lens AMO AR40NB].

BACKGROUND

More and more foldable acrylic lenses are implanted besides silicone and polymethylmethacrlyate (PMMA) lenses through small incision unfolding in the capsular bag. Complications were observed such as forceps marks, surface scratches and so called glistenings. Therefore, a profound clinical evaluation of a former by Ioptex marketed acrylic lens which has been readapted by Allergan also with regard to a special developed injector seemed to be necessary.

PATIENTS AND

METHODS

Forty-four patients were enrolled within 14 days in a one-year, unilateral, non-comparative, open clinical study implanted with the AMO AR40NB hydrophobic acrylic IOL. This foldable acrylic IOL with biconvex optic design and extruded polymethylmethacrylate (PMMA) haptics (AR40) was implanted either using a folding forceps or the AMO AR40NB Insertion System through a temporal limbal hinged incision of 3.2 to 3.5 mm.

RESULTS

One-year postoperatively, 85% (28/33) best corrected distance visual acuity (BSCVA) of 0.5 (20/40) or better was reported, with 39% (13/33) reported BSCVA of 1.0 (20/20) or better. Those not achieving 0.5 or better suffered from either macular degeneration or other ophthalmic pathologies. There were no reports of surgical complications and ease of lens insertion was rated by the surgeon better than most in 98% of all cases. There were no persistent adverse events.

CONCLUSION

Results from this study of the AR40 demonstrate good clinical performance characteristics as well as better implantation with the injector Unfolder Sapphire.