Abstract

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. Fernández-Vega Ophthalmological Institute, Oviedo, Spain. Prospective nonrandomized clinical study. The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, pIOL vault, and adverse effects were evaluated 12 months postoperatively. 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. 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. No author has a financial or proprietary interest in any material or method mentioned.

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