Clinical outcomes after implantation of a posterior chamber collagen copolymer phakic intraocular lens with a central hole for myopic correction

PURPOSE: To evaluate the efficacy, predictability, safety, and stability of a new-model posterior chamber Implantable Col lamer Lens phakic intraocular lens (pIOL) (V4c Visian) to correct myopia. SETTING: Private practice, Oviedo, Spain. DESIGN: Case series. METHODS: This study enrolled patients who had implantation of a new pIOL design with a central hole for more natural aqueous flow, eliminating the need for neodymium:YAG iridotomy or peripheral iridectomy. The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refractive error, intraocular pressure (IOP), endothelial cell count, central vault, and adverse events were evaluated 6 months postoperatively. RESULTS: The study enrolled 138 eyes (70 patients). The mean spherical equivalent decreased from -8.73 diopters (D) +/- 2.54 (SD) preoperatively to -0.03 +/- 0.19 D 6 months postoperatively; 98.5% of eyes were within +/- 0.50 D and 100% of eyes were within +/- 1.00 D. The mean UDVA and CDVA were 20/20 or better in 92.1% and 95.0% of eyes, respectively, at 6 months. The safety and efficacy indices were 1.01 and 1.00, respectively. Postoperatively, the IOP remained stable over time. No significant rises in IOP (including pupillary block) and no secondary cataract were found. After 6 months, the mean vault was 482.7 +/- 210.5 mu m (range 90 to 970 mu m) and the mean endothelial cell loss was 8.5%. CONCLUSIONS: Implantation of the pIOL was effective, predictable, safe, and stable for the correction of moderate to high myopic errors. This design, which avoids iridotomy or iridectomy, provided good IOP outcomes. (C) 2013 ASCRS and ESCRS