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Li Chen,1,* Pooja Khamar,2,* Ying Wang,3 Hong Fu,1 Rohit Shetty2 1Johnson & Johnson Surgical Vision, Inc., Milpitas, CA, USA; 2Narayana Nethralaya Eye Hospital, Bangalore, India; 3Johnson & Johnson Surgical Vision, Inc., Irvine, CA, USA*These authors contributed equally to this workCorrespondence: Li Chen, Johnson & Johnson Surgical Vision, Inc., 510 Cottonwood Drive, Milpitas, CA, 95035, USA, Tel +1 408 273 4062, Email lchen185@its.jnj.comPurpose: To evaluate the changes of higher-order wavefront aberrations following the Smooth Incision Lenticular Keratomileusis (SILKTM) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITATM Femtosecond Platform.Methods: This prospective study included 24 eyes that underwent SILK procedure using one ELITA femtosecond laser system for the correction of myopic refractive errors with and without astigmatism. Preoperative and postoperative 1-day, 1-week, 1-month, 3-month, and 9-month eye exams were measured with a commercial wavefront aberrometer (iDESIGN® Refractive Studio, Johnson & Johnson Surgical Vision, Inc). Wavefront aberrations up to the 6th order Zernike coefficients, including coma Z(3, − 1) and Z(3, 1), spherical aberration Z(4, 1), and the wavefront error of all higher-order aberrations (HOAs RMS), were evaluated across a 6 mm pupil.Results: The mean manifest refractive spherical equivalent changed from the preoperative refractions − 3.82 ± 1.26 D (range − 6.00 to − 2.25 D) to the postoperative refractions − 0.20 ± 0.15 D (range − 0.50 to 0.00 D) at the 9-month follow-up. Compared to baseline preoperative HOAs, the mean postoperative HOAs were significantly increased at the 1-day follow-up. On average, at the 9-month postoperative assessment the vertical coma Z(3, − 1) was − 0.054 ± 0.186 μm, horizontal coma Z(3, 1) was 0.016 ± 0.124 μm, spherical aberration Z(4, 0) was 0.046 ± 0.163 μm, and HOAs RMS was 0.363 ± 0.115 μm across a 6 mm pupil. There is no significant difference in the mean HOAs starting at 1-week follow-up for the horizontal coma (P = 0.346) and spherical aberration (P = 0.095).Conclusions: The visual outcomes demonstrated that the SILK procedure for refractive lenticule extraction using ELITA femtosecond laser system is effective and predictable for the correction of myopic refractive errors with and without astigmatism. The ELITA femtosecond laser system induced minimal HOAs in surgical eyes following the SILK procedures. These results demonstrate fast corneal recovery starting at 1-week follow-up, and spherical aberration was not induced.Keywords: wavefront aberrations, corneal refractive surgery, laser-assisted lenticule extraction, smooth incision lenticular keratomileusis |