PURPOSE: To evaluate outcomes in patients with myopia up to -12.00 diopters (D), with or without astigmatism up to 6.00 D, who underwent LASIK with the WaveLight Refractive Suite (Alcon Laboratories, Inc., Fort Worth, TX). METHODS: This multicenter, prospective, single-arm study evaluated patients at baseline, on the day of surgery, and 1 day and 1, 3, and 6 months postoperatively. The primary outcome was comparison of 1-month postoperative binocular uncorrected distance visual acuity (UDVA) with preoperative binocular corrected distance visual acuity (CDVA). Noninferiority was defined as the upper bound of the 95% confidence interval less than 0.1 logMAR. Post-hoc analyses for superiority were conducted for monocular and binocular CDVA at 1, 3, and 6 months. Continuous variables were summarized using mean (95% confidence interval), median, quartiles, standard deviation, minimum and maximum, and categorical variables as counts and percentages. RESULTS: Of the 96 patients (54% female, mean age: 31 years), 5 underwent monocular and 91 binocular LASIK surgery (187 eyes). Preoperatively, mean binocular CDVA was -0.025 ± 0.126 logMAR, mean binocular UDVA was 1.148 ± 0.626 logMAR, and meanmanifest spherical refraction equivalent was -3.67 ± 1.98 D. Postoperative binocular UDVA at 1 month (-0.088 ± 0.107 logMAR) was noninferior to preoperative binocular CDVA. Postoperative binocular UDVA at 1, 3 (-0.098 ± 0.107 logMAR), and 6 months (-0.105 ± 0.113 logMAR) were significantly superior to preoperative binocular CDVA (P < .0001 each). CONCLUSIONS: The primary study objective was exceeded; postoperative UDVA was significantly superior to preoperative CDVA in patients with myopia and myopia with astigmatism who underwent LASIK with the WaveLight Refractive Suite. [J Refract Surg. 2017;33(5):322-328.]. Copyright 2017, SLACK Incorporated.
RCT Entities:
PURPOSE: To evaluate outcomes in patients with myopia up to -12.00 diopters (D), with or without astigmatism up to 6.00 D, who underwent LASIK with the WaveLight Refractive Suite (Alcon Laboratories, Inc., Fort Worth, TX). METHODS: This multicenter, prospective, single-arm study evaluated patients at baseline, on the day of surgery, and 1 day and 1, 3, and 6 months postoperatively. The primary outcome was comparison of 1-month postoperative binocular uncorrected distance visual acuity (UDVA) with preoperative binocular corrected distance visual acuity (CDVA). Noninferiority was defined as the upper bound of the 95% confidence interval less than 0.1 logMAR. Post-hoc analyses for superiority were conducted for monocular and binocular CDVA at 1, 3, and 6 months. Continuous variables were summarized using mean (95% confidence interval), median, quartiles, standard deviation, minimum and maximum, and categorical variables as counts and percentages. RESULTS: Of the 96 patients (54% female, mean age: 31 years), 5 underwent monocular and 91 binocular LASIK surgery (187 eyes). Preoperatively, mean binocular CDVA was -0.025 ± 0.126 logMAR, mean binocular UDVA was 1.148 ± 0.626 logMAR, and mean manifest spherical refraction equivalent was -3.67 ± 1.98 D. Postoperative binocular UDVA at 1 month (-0.088 ± 0.107 logMAR) was noninferior to preoperative binocular CDVA. Postoperative binocular UDVA at 1, 3 (-0.098 ± 0.107 logMAR), and 6 months (-0.105 ± 0.113 logMAR) were significantly superior to preoperative binocular CDVA (P < .0001 each). CONCLUSIONS: The primary study objective was exceeded; postoperative UDVA was significantly superior to preoperative CDVA in patients with myopia and myopia with astigmatism who underwent LASIK with the WaveLight Refractive Suite. [J Refract Surg. 2017;33(5):322-328.]. Copyright 2017, SLACK Incorporated.