Outcomes of ZB5M angle-supported anterior chamber phakic intraocular lenses at 12 years

PURPOSE: To evaluate the visual and refractive stability and the potential long-term risks associated with ZB5M phakic intraocular lens (PIOL) implantation. METHODS: A retrospective, non-randomized, cumulative clinical study was performed over 12 years in a consecutive group of 225 eyes implanted with the ZB5M PIOL. The main analyzed variables were visual and refractive outcomes (best spectacle-corrected visual acuity {[}BSCVA], uncorrected visual acuity {[}UCVA], and spherical equivalent, endothelial cell density, and postoperative complications. RESULTS: Mean preoperative spherical equivalent refraction was -17.23+/-7.69 diopters (D) and 12 years post-operatively it was -180+/-0.80 D. Mean BSCVA at 1- and 12-year follow-up was 0.38+/-0.19 and 0.57+/-0.18, respectively (Wilcoxon test, P < .001). At 12 years post-operatively, 3.5\% of eyes lost >= 2 lines of BSCVA. An inital 10.6\% reduction in endothelial cell density was noted in the first year, followed by a mean annual rate of decrease of 1.78\%. The cumulative incidence of pupil ovalization was 34.7\% (78 eyes), and there was no statistical correlation with endothelial cell impairment. Bilateral hypertensive uveitis was diagnosed in 3 (1.33\%) eyes. CONCLUSIONS: The ZB5M PIOL offers good refractive outcomes and stability in the long-term; however, endothelial cell loss increases over 12 years, requiring annual endothelial cell counts.