Real-World Study Assessing the Efficacy and Safety of a Novel KLEx Procedure with a Next-Generation Femtosecond Laser for Refractive Error Correction

Purpose: ELITA Femtosecond Laser System (Johnson & Johnson) is a next-generation ophthalmic laser platform designed for Smooth Incision Lenticular Keratomileusis (SILK). A retrospective study evaluated refractive outcomes, visual acuity, higher-order aberrations (HOAs), tear film parameters, and dry eye symptoms 30 days postoperatively. Patients and Methods: A retrospective, non-comparative, case series analyzing real-world data from patients with myopia treated using the SILK procedure with the ELITA femtosecond laser. The study included 144 eyes from 73 consecutive patients (47 female, 26 male) with myopia (-4.51 ± 1.36 D; range -1.50 D to -8.250 D). Refraction and uncorrected distance visual acuity (UDVA) were assessed preoperatively and at 1, 7, and 30 days postoperatively. A subset of 18 patients (36 eyes) underwent additional evaluation of tear film (Keratograph, LipiView, Schirmer II, NIBUT), dry eye symptoms (OSDI), and HOAs/contrast sensitivity (iTrace). Results: At 30-days, 96.5% of eyes (139/144) achieved 20/20 UDVA while the remaining 3.5% achieved 20/25. The mean spherical equivalent was -0.22 ± 0.68 D. No significant changes were observed in tear film metrics, HOAs, or contrast sensitivity. A statistically significant difference in vertical coma was noted (0.05 ± 0.04 µm vs 0.1 ± 0.09 µm, P = 0.008), though not clinically relevant. No serious adverse events occurred. Conclusion: The SILK procedure with the ELITA femtosecond laser platform is safe and effective for myopia correction (with and without astigmatism), with no detrimental effect on tear film stability, dry eye symptoms, or visual quality at 30 days post-surgery.