Toric phakic intraocular lens: European multicenter study.

OBJECTIVE: To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after implantation of Artisan toric phakic intraocular lenses (TPIOLs) for the correction of myopia or hyperopia with astigmatism. DESIGN: Prospective, nonrandomized, comparative (self-controlled) multicenter trial. PARTICIPANTS: Seventy eyes of 53 patients (mean, 35 years; range, 22-59 years) with preoperative spherical equivalent between +6.50 and -21.25 diopters (D) and cylinder between 1.50 and 7.25 D. METHODS: Seventy eyes underwent implantation of a TPIOL with an optical zone of 5.0 mm (Artisan, Ophtec, Groningen, The Netherlands). The dioptric power of the intraocular lens was calculated by considering refraction, keratometry, and anterior chamber depth. The follow-up was 6 months in all cases. Lenses were available in powers ranging from +12.0 D to -23.5 D (spherical equivalent) in 0.5-D increments, with additional cylinder from 1.0 D to 7.0 D, also in 0.5-D increments. MAIN OUTCOME MEASURES: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, endothelial cell count (ECC), intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, subjective complaints, and patient satisfaction. RESULTS: Eyes were divided into group A, myopia (n = 48), with an average preoperative spherical equivalent of -8.90 +/- 4.52 D, and group B, hyperopia (n = 22), with an average preoperative spherical equivalent of +3.25 +/- 1.98 D. No eyes in either group experienced a loss in BSCVA, and 46 eyes gained 1 or more lines of their preoperative BSCVA. In 62 eyes (88.6%), UCVA was 20/40 or better. There was a significant reduction in spherical errors and astigmatism in all cases after surgery. All eyes of both groups were within +/-1.00 D of target refraction, and 51 eyes (72.9%) were within +/-0.50 D of target refraction. There was a 4.5% mean total loss of ECC during the first 6 months. No serious complications were observed. Overall patient satisfaction was very high. CONCLUSIONS: Six-month clinical trial results demonstrate that implantation of the Artisan TPIOL safely, predictably, and effectively reduced or eliminated high ametropia and astigmatism with one procedure. The refractive effect was stable at 6 months after surgery.

Comparison of iris-fixed Artisan lens implantation with excimer laser in situ keratomileusis in correcting myopia between -9.00 and -19.50 diopters: a randomized study.

OBJECTIVE: To compare Artisan lens implantation with laser in situ keratomileusis (LASIK) for the correction of myopia between -9.00 and -19.50 diopters. DESIGN: Prospective randomized clinical trial. PARTICIPANTS: Ninety eyes of 61 consecutive patients were enrolled in the study. INTERVENTION: Forty-five eyes (50%) received Artisan lens, and 45 eyes (50%) received LASIK; the procedure assigned to each eye was randomized. Eighteen patients (29.5%) received Artisan lens in one eye and LASIK in the other. MAIN OUTCOME MEASURES: Slit-lamp microscopy, manifest refraction, uncorrected and spectacle-corrected visual acuity, contrast sensitivity, and specular microscopy were performed before surgery, and 1, 3, 6, and 12 months after surgery. Patient satisfaction and preference were assessed by a subjective questionnaire. RESULTS: At 1 year, 43 eyes (95.6%) from the Artisan group and 41 eyes (91.1%) from the LASIK group were examined, the mean spherical equivalent refraction was -0.64 +/- 0.8 diopter in the Artisan eyes and -0.87 +/- 0.8 in the LASIK eyes. The uncorrected visual acuity was 20/20 or better in 9 Artisan eyes (20.9%) and 5 LASIK eyes (12.2%) and 20/40 or better in 38 Artisan eyes (88.4%) and 24 LASIK eyes (58.5%); no Artisan eyes and 5 LASIK eyes (12.2%) lost 2 or more Snellen lines of spectacle-corrected visual acuity. One Artisan eye (2.3%) and six LASIK eyes (14.6%) reported severe night glare; the Artisan lens was exchanged with a larger optic diameter lens. Mean endothelial cell loss at 1 year was 0.7 +/- 1.1 cells/mm(2) in the Artisan eyes and 0.3 +/- 0.9 cells/mm(2) in the LASIK eyes. Contrast sensitivity curve decreased by 2 or more lines in two Artisan (4.7%) and six LASIK eyes (14.6%). Of the 18 patients who received both surgeries, one in each eye, 13 patients (72.2%) preferred the Artisan procedure because of the better quality of vision. CONCLUSIONS: In this study, Artisan lens implantation and LASIK were found to be similarly effective, stable, and reasonably safe for the correction of myopia between -9.00 and -19.50 diopters. Better uncorrected and spectacle-corrected visual acuity and contrast sensitivity, a lower enhancement rate, and exchangeability are the main advantages of Artisan lens implantation. Thirteen (72.2%) of the 18 patients who received the Artisan lens in one eye and LASIK in the other preferred the Artisan lens to the LASIK, mainly because of the better quality of vision.