OBJECTIVE: To compare refractive performance and safety of laser in situ keratomileusis (LASIK) and Artisan phakic intraocular lens (PIOL) for moderately high myopia. DESIGN: A prospective, randomized trial with paired eye control. PARTICIPANTS: Twenty-five patients with myopia ranging from -8.00 to -12.00 diopters (D). INTERVENTION: For each patient, one eye received LASIK and the other one was implanted with an Artisan phakic intraocular lens. The treated eye and the surgical technique were randomized. MAIN OUTCOME MEASURES: Primary outcome measure was spherical equivalent refraction. Main secondary outcome measures were the change of two or more lines and safety index (ratio postoperative to preoperative best-corrected visual acuity). RESULTS: One year after surgery, the mean spherical equivalent refraction was -0.74 +/- 0.67 D for LASIK-treated eyes and -0.95 +/- 0.45 D for Artisan-treated eyes, and the majority of LASIK-treated eyes (64%) and Artisan-treated eyes (60%) were within +/-1.00 D of the intended result. At 1 month, the mean spherical equivalent refraction was -0.28 +/- 0.71 D for LASIK and -1.07 +/- 0.59 D for Artisan (P < 0.01). The changes of two or more lines were in favor of Artisan (P < 0.05). The safety index was significantly better for Artisan (1.12 +/- 0.21) than for LASIK (0.99 +/- 0.17) at 1 year (P < 0.02). CONCLUSIONS: In cases of moderately high myopia, LASIK and Artisan phakic intraocular lenses seemed to produce a similar predictability. The best-corrected visual acuity and subjective evaluation of quality of vision were better for Artisan.
RCT Entities:
OBJECTIVE: To compare refractive performance and safety of laser in situ keratomileusis (LASIK) and Artisan phakic intraocular lens (PIOL) for moderately high myopia. DESIGN: A prospective, randomized trial with paired eye control. PARTICIPANTS: Twenty-five patients with myopia ranging from -8.00 to -12.00 diopters (D). INTERVENTION: For each patient, one eye received LASIK and the other one was implanted with an Artisan phakic intraocular lens. The treated eye and the surgical technique were randomized. MAIN OUTCOME MEASURES: Primary outcome measure was spherical equivalent refraction. Main secondary outcome measures were the change of two or more lines and safety index (ratio postoperative to preoperative best-corrected visual acuity). RESULTS: One year after surgery, the mean spherical equivalent refraction was -0.74 +/- 0.67 D for LASIK-treated eyes and -0.95 +/- 0.45 D for Artisan-treated eyes, and the majority of LASIK-treated eyes (64%) and Artisan-treated eyes (60%) were within +/-1.00 D of the intended result. At 1 month, the mean spherical equivalent refraction was -0.28 +/- 0.71 D for LASIK and -1.07 +/- 0.59 D for Artisan (P < 0.01). The changes of two or more lines were in favor of Artisan (P < 0.05). The safety index was significantly better for Artisan (1.12 +/- 0.21) than for LASIK (0.99 +/- 0.17) at 1 year (P < 0.02). CONCLUSIONS: In cases of moderately high myopia, LASIK and Artisan phakic intraocular lenses seemed to produce a similar predictability. The best-corrected visual acuity and subjective evaluation of quality of vision were better for Artisan.
Authors: Virgilio Galvis; John F Villamil; María Fernanda Acuña; Paul A Camacho; Jesús Merayo-Lloves; Alejandro Tello; Sandra Lizeth Zambrano; Juan José Rey; Juan Vicente Espinoza; Angélica María Prada Journal: Graefes Arch Clin Exp Ophthalmol Date: 2019-10-28 Impact factor: 3.117