PURPOSE: To evaluate the refractive, visual, and morphometric changes after implantation with a foldable iris-fixated phakic intraocular lens (pIOL) to correct myopia or astigmatism.
SETTING: University Eye Clinic Maastricht, the Netherlands.
DESIGN: Prospective case series.
METHODS: We evaluated patients implanted with the Artiflex Myopia (Toric) iris-fixated pIOL as of January 2004. Measurements were performed annually and reported after 1 and 5 years.
RESULTS: The study included 481 eyes (277 patients; age 39.8±10.9 years [SD]). Five years postoperatively 91% of eyes were within ±1.0 D of target, and the mean myopisation over a 5 year period was 0.22 diopters (p<0.001). The logMAR CDVA increased by a mean 0.015 (p=0.015) over 5 years; 88% of eyes had a CDVA of 20/20 or better and 5.5% lost 2 or more lines of CDVA. Mean UDVA increased by 0.045 logMAR over 5 years (p<0.001); 96% reached an UDVA of 20/40 or more. Anterior chamber depth (ACD) decreased by 0.04 mm (p<0.001), and axial length (AXL) increased by 0.23 mm (p<0.001) over 5 years. Chronic endothelial cell loss showed a 5-year decline of 320 cells/mm2 in the myopic and 310 cells/mm2 in the toric subgroups (p<0.001). Cataract resulted in pIOL explantation in 4.0% of eyes (mean survival 59.0±40.0 months); higher preoperative age (hazard ratio [HR], 1.13; p<0.001) and smaller ACD (HR, 6.80; p= 0.035) were risk factors for shorter survival due to cataract formation.
CONCLUSION: Over 5 years logMAR CDVA and UDVA decreased significantly due to myopisation caused by lenticular changes and AXL elongation.