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Purpose: To evaluate visual outcomes following the Smooth Incision Lenticular Keratomileusis (SILKTM) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITATM Femtosecond Laser System.Patients and Methods: A prospective, multicenter, single-arm, open-label clinical study was conducted. Eighty-five myopic subjects (n = 170 eyes), aged 18 years or older, with manifest refractive spherical equivalent (MRSE) up to − 12.00 D and astigmatism up to − 6.00 D, were treated binocularly using the ELITA femtosecond laser and followed up for 6 months. Intended correction was emmetropia for all eyes. The primary outcome measures included post-operative uncorrected and corrected distance visual acuity (UDVA and CDVA). Secondary outcome measures included surgeon's rating for ease of lenticule extraction, predictability, safety, and stability.Results: A total of 170 eyes of 85 patients underwent SILK. Preoperative mean MRSE was − 4.14 D ± 1.32 D (range − 1.38 D to − 8.88 D) and the mean cylinder was − 0.77 D ± 0.62 D. Intraoperative surgeon ease of lenticule dissection was rated as grade 0 or 1 in 85.3% of eyes (no/only mild dissection needed). UDVA at 1 day, 1 week, 1 month, and 6 months was 20/20 or better in 65.9%, 85.4%, 91.5%, and 96% of eyes, respectively. No eyes lost any lines of CDVA at 6 months compared to the preoperative. The postoperative MRSE was stable over time, ranging from − 0.34 D ± 0.24 D at 1 month to − 0.33 D ± 0.23 D at 6 months. MRSE predictability (± 0.50 D) was 93.5% (129/138) at 3 months and 91.1% (113/124) at 6 months. No serious adverse events were noted.Conclusion: The SILK procedure with the ELITA Femtosecond Laser System is safe and effective for the treatment of myopic refractive errors with and without astigmatism. Fast visual recovery was demonstrated, with stability achieved by 3 months. [ABSTRACT FROM AUTHOR]

This document is a response to a letter from Dr. Alpins regarding a publication on the safety and effectiveness of the Smooth Incision Lenticular Keratomileusis (SILK™) procedure for correcting refractive errors. The authors of the publication disagree with Dr. Alpins' comments on their method and terminology for astigmatism analysis. They explain that they followed the recommended method and terminology from the American National Standards Institute (ANSI) and that their references were appropriate for comparing treatment results, not data analysis methods. The authors also disclose their affiliations and conflicts of interest. [Extracted from the article]

This document is a corrigendum for an article titled "Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK™) Using the ELITA™ Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors." The authors have identified errors in Figure 3A and B, where the X and Y axes and other numbers should be shown as negative instead of positive. The correct Figure 3 is provided in the document. The authors apologize for these errors. [Extracted from the article]

Purpose: To evaluate visual outcomes following the Smooth Incision Lenticular Keratomileusis (SILK TM ) procedure for correction of myopic refractive errors with and without astigmatism, using the ELITA TM Femtosecond Laser System., Patients and Methods: A prospective, multicenter, single-arm, open-label clinical study was conducted. Eighty-five myopic subjects (n = 170 eyes), aged 18 years or older, with manifest refractive spherical equivalent (MRSE) up to -12.00 D and astigmatism up to -6.00 D, were treated binocularly using the ELITA femtosecond laser and followed up for 6 months. Intended correction was emmetropia for all eyes. The primary outcome measures included post-operative uncorrected and corrected distance visual acuity (UDVA and CDVA). Secondary outcome measures included surgeon's rating for ease of lenticule extraction, predictability, safety, and stability., Results: A total of 170 eyes of 85 patients underwent SILK. Preoperative mean MRSE was -4.14 D ± 1.32 D (range -1.38 D to -8.88 D) and the mean cylinder was -0.77 D ± 0.62 D. Intraoperative surgeon ease of lenticule dissection was rated as grade 0 or 1 in 85.3% of eyes (no/only mild dissection needed). UDVA at 1 day, 1 week, 1 month, and 6 months was 20/20 or better in 65.9%, 85.4%, 91.5%, and 96% of eyes, respectively. No eyes lost any lines of CDVA at 6 months compared to the preoperative. The postoperative MRSE was stable over time, ranging from -0.34 D ± 0.24 D at 1 month to -0.33 D ± 0.23 D at 6 months. MRSE predictability (± 0.50 D) was 93.5% (129/138) at 3 months and 91.1% (113/124) at 6 months. No serious adverse events were noted., Conclusion: The SILK procedure with the ELITA Femtosecond Laser System is safe and effective for the treatment of myopic refractive errors with and without astigmatism. Fast visual recovery was demonstrated, with stability achieved by 3 months., Competing Interests: The authors have made the following disclosures: M.S.S.: Consultant to Johnson & Johnson Surgical Vision, Inc. R.S., P.K., and R.M perform research supported by Johnson & Johnson Surgical Vision, Inc. B.L.S., Y.W., H.F., A.P.V., and M.L: Employees of Johnson & Johnson Surgical Vision, Inc. The authors report no other conflicts of interest in this work., (© 2023 Sachdev et al.)