Purpose: To compare the visual and refractive out-comes of femtosecond laser-assisted LASIK with small-incision lenticule extraction (SMILE) in terms of visual acuity, contrast sensitivity, aberrations, and dry eye.
Methods: A single-center prospective randomized study in which patients diagnosed as having myopia presenting for refractive correction were allocated to either a LASIK or SMILE group. The primary outcome measures were refractive efficacy, predictability, and safety, postoperative contrast sensitivity, aberrations, and dry eye status. Patients were followed up at days 1 and 15 and 3 months; postoperative uncorrected visual acuity (UCVA), aberrations, dry eye, and contrast sensitivity were recorded and compared to preoperative data. Two postoperative subjective questionnaires were used to assess pain, pricking sensation, redness, glare, and overall patient satisfaction.
Results: At day 1 postoperatively, 48 (96%) of 50 eyes in the SMILE group achieved a UCVA of 20/20 compared with 46 (92%) of 50 eyes in the LASIK group. At day 15 postoperatively, contrast sensitivity was similar in the two groups (P = .15), but by 3 months, it was better in the SMILE group than the LASIK group at all spatial frequencies (P < .0001). At 3 months postoperatively, 42 (84%) eyes in each group achieved a UCVA of 20/20, with 6 (12%) eyes in the SMILE group and 2 (4%) eyes in the LASIK group achieving 20/15. Higher-order aberrations at 3 months postoperatively were significantly higher in the LASIK group (0.437 + 0.103 pm) than in the SMILE group (0.267 + 0.07 pm; P < .001). Postoperative dry eye and glare were significantly more common following LASIK (P < .001).
Conclusions: Three-month results demonstrate that refractive accuracy, dry eye, contrast, and induced aberrations are better following SMILE rather than LASIK.