Phakic refractive lens implantation in high myopic patients: One-year results

Purpose: To evaluate the efficacy and safety of implantation of a new posterior chamber phakic refractive lens (PRL, Ciba Vision Surgical) in highly myopic eyes. Setting: Department of Ophthalmology, Medical School, University of Crete, Vardinoyannion Eye Institute of Crete, Crete, Greece. Methods: Thirty-four myopic eyes of 19 patients were treated for high myopia with implantation of a silicone PRL in the posterior chamber. Mean patient age was 29.0 years +/-7.9 (SD) (range 18 to 44 years). Manifest refraction in spherical equivalent (MR), uncorrected (UCVA) and best corrected (BCVA) visual acuity (decimal scale), intraocular pressure, higher-order aberrations (root-mean-square[RMS] wavefront error measured with a Shack-Hartmann wavefront sensor WASCA analyzer [Carl Zeiss, Meditec]), possible complications, and subjective symptoms were evaluated. Results: Phakic refractive lenses were successfully implanted in all eyes. Mean follow-up was 17.17+/-3.76 months (range 12 to 24 months). There was a statistically significant reduction in the MR (from -14.70 D +/-2.65 D [range -20.75 D to -10.50 D] to -0.61 D +/-0.89 D [range -2.25 D to 1.00 D]) (P<.001). Twenty-seven (79%) and 15 eyes (44%) were within +/- 1.00 D and +/- 0.50 D of target refraction, respectively. Mean UCVA significantly improved (from counting fingers to 0.62 +/- 0.28 (range 0.08 to 1.20) (P<.001). Mean BCVA also improved from 0.70+/-0.24 (range 0.10 to 1.00) to 0.85+/-0.24 (range 0.10 to 1.20) (P<0.001). Overall, there was a mean increase in BCVA of 1.5 +/- 1.5 lines (range loss of 2 lines to gain of 5 lines). There was no statistically significant difference in higher-order aberrations after PRL implantation (pre-PRL RMS: 0.18 mu m +/- 0.08 mu m [range 0.09 mu m to 0.38 mu m]; post-PRL RMS: 0.21 mu m +/- 0.08 mu m; [range 0.05 mu m to 0.38 mu m]) (P=.12). Conclusion: The PRL showed encouraging results in treating high myopia. Additional patients and longer follow-up period are needed to detect the long-term efficacy and safety of this refractive lens.