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.
RCT Entities:
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.