Prospective Evaluation of Outcomes in Patients Undergoing Treatment for Myopia Using the WaveLight Refractive Suite
Abstract
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.]
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