Carlos Lisa1, José Fernando Alfonso2, Belén Alfonso-Bartolozzi1, Luis Fernández-Vega1, Cari Pérez-Vives1, Robert Montés-Micó1. 1. From Fernández-Vega Ophthalmological Institute (Lisa, Alfonso, Alfonso-Bartolozzi, Fernández-Vega) and the Surgery Department (Alfonso, Fernández-Vega), School of Medicine, University of Oviedo, Oviedo, and the Optics Department (Pérez-Vives, Montés-Micó), Optometry Research Group, Faculty of Physics, University of Valencia, Valencia, Spain. 2. From Fernández-Vega Ophthalmological Institute (Lisa, Alfonso, Alfonso-Bartolozzi, Fernández-Vega) and the Surgery Department (Alfonso, Fernández-Vega), School of Medicine, University of Oviedo, Oviedo, and the Optics Department (Pérez-Vives, Montés-Micó), Optometry Research Group, Faculty of Physics, University of Valencia, Valencia, Spain. Electronic address: j.alfonso@fernandez-vega.com.
Abstract
PURPOSE: To evaluate the predictability, stability, safety, and efficacy of Visian V4b Implantable Collamer Lens phakic intraocular lens (pIOL) implantation to treat varying degrees of myopia. SETTING: Fernández-Vega Ophthalmological Institute, Oviedo, Spain. DESIGN: Prospective nonrandomized clinical study. METHODS: The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, pIOL vault, and adverse effects were evaluated 12 months postoperatively. RESULTS: The study enrolled 121 eyes (68 patients). The mean spherical equivalent decreased from -8.61 diopters (D) ± 3.41 (SD) (range -18.75 to -2.25 D) preoperatively to -0.18 ± 0.29 D (range -1.25 to 0.50 D) 12 months postoperatively; 97 eyes (80.2%) were within ±0.25 D of the target refraction and 114 eyes (94.2%) were within ±0.50 D (r(2) = 0.99). The mean Snellen decimal UDVA and CDVA were 0.91 ± 0.17 and 0.97 ± 0.09, respectively. Postoperatively, the UDVA was 20/20 or better in 80 eyes (66.1%) and 20/40 or better in 115 eyes (95.0%). The mean efficacy index was 0.96 ± 0.14. The CDVA was 20/20 or better in 103 eyes (85.1%) and 20/40 or better in all eyes. No eye lost lines of CDVA, and 22 eyes (18.2%) gained 1 or more lines of CDVA. The mean safety index was 1.04 ± 0.10. There were no intraoperative complications. CONCLUSIONS: The predictability, safety, and effectiveness of the pIOL were good throughout the 12-month follow-up and comparable to outcomes reported for previous pIOL models. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.
PURPOSE: To evaluate the predictability, stability, safety, and efficacy of Visian V4b Implantable Collamer Lens phakic intraocular lens (pIOL) implantation to treat varying degrees of myopia. SETTING: Fernández-Vega Ophthalmological Institute, Oviedo, Spain. DESIGN: Prospective nonrandomized clinical study. METHODS: The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, pIOL vault, and adverse effects were evaluated 12 months postoperatively. RESULTS: The study enrolled 121 eyes (68 patients). The mean spherical equivalent decreased from -8.61 diopters (D) ± 3.41 (SD) (range -18.75 to -2.25 D) preoperatively to -0.18 ± 0.29 D (range -1.25 to 0.50 D) 12 months postoperatively; 97 eyes (80.2%) were within ±0.25 D of the target refraction and 114 eyes (94.2%) were within ±0.50 D (r(2) = 0.99). The mean Snellen decimal UDVA and CDVA were 0.91 ± 0.17 and 0.97 ± 0.09, respectively. Postoperatively, the UDVA was 20/20 or better in 80 eyes (66.1%) and 20/40 or better in 115 eyes (95.0%). The mean efficacy index was 0.96 ± 0.14. The CDVA was 20/20 or better in 103 eyes (85.1%) and 20/40 or better in all eyes. No eye lost lines of CDVA, and 22 eyes (18.2%) gained 1 or more lines of CDVA. The mean safety index was 1.04 ± 0.10. There were no intraoperative complications. CONCLUSIONS: The predictability, safety, and effectiveness of the pIOL were good throughout the 12-month follow-up and comparable to outcomes reported for previous pIOL models. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.