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Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILK™) Using the ELITA™ Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors [Response to Letter]
Authors Sachdev MS, Shetty R, Khamar P, Malik R, Schwam BL, Wang Y, Fu H, Voorhees AP, Laron M
Received 23 July 2024
Accepted for publication 8 August 2024
Published 21 August 2024 Volume 2024:18 Pages 2337—2338
Mahipal S Sachdev,1 Rohit Shetty,2 Pooja Khamar,2 Raghav Malik,1 Brian L Schwam,3 Ying Wang,3 Hong Fu,3 Andrew P Voorhees,3 Michal Laron3
1Centre for Sight, New Delhi, India; 2Narayana Nethralaya Eye Hospital, Bangalore, India; 3Johnson & Johnson Surgical Vision, Inc., Milpitas, CA, USA
Correspondence: Michal Laron, Johnson and Johnson Surgical Vision, Inc, 510 Cottonwood Drive, Milpitas, CA, 95035, USA, Tel +1 408 273 5802, Email [email protected]
View the original paper by Dr Sachdev and colleagues
This is in response to the Letter to the Editor
Dear editor
The authors of the publication, Safety and Effectiveness of Smooth Incision Lenticular Keratomileusis (SILKTM) Using the ELITATM Femtosecond Laser System for Correction of Myopic and Astigmatic Refractive Errors1 (the paper), would like to respond to the Letter to the Editor from Dr. Alpins published on July 8, 20242 (the letter).
The paper1 reported on the first clinical study demonstrating the safety and effectiveness of SILKTM and easy lenticule removal for the correction for myopic and astigmatic refractive errors. In the letter,2 Dr. Alpins commented that the paper1 used “inadequate” method, terminology, and references with respect to vector analysis for astigmatism, with which we disagree.
We strove and will continue to strive to apply the highest standards to everything we do. For statistical analysis for astigmatism, the clinical study protocol adopted the method and terminology recommended by the Astigmatism Project Group of the American National Standards Institute (ANSI) Z80.11 Working Group on Laser Systems for Corneal Reshaping3 (ANSI paper), which was comprised of experts in astigmatism analyses from academia, government, and industry. The ANSI recommendation is based on an extensive literature review in the field of vector analysis for astigmatism. The Centre for Sight Institutional Ethics Committee and Narayana Nethralaya Ethics Committee reviewed and accepted the clinical study protocol prior to the start of the study.
With respect to Dr. Alpins’ comment on the ANSI paper3 in the letter,2 it is worth pointing out that the ANSI paper appropriately recognizes all the significant contributions in this field, including Dr. Alpins’ significant contributions, and it even recommends readers to read Dr. Alpins’ review paper on vector analyses. In the letter,2 Dr. Alpins also questioned why the two papers,4,5 ie, references 31 and 32 in the paper,1 cite his work but the paper1 does not. Our response is that those two papers use the Alpins method and therefore should directly reference Dr. Alpins’ work. We referenced the two papers for the purpose of comparing the astigmatism treatment results only but not for comparing the respective data analysis methods. Given that our paper focused on presenting all aspects of the safety and effectiveness of the SILKTM procedure for myopic refractive correction, the method, terminology, and references used in our paper are appropriate, comprehensive, and clear for readers in the ophthalmic field.
Disclosure
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 communication.
References
1. Sachdev MS, Shetty R, Khamar P, et al. Safety and effectiveness of smooth incision lenticular keratomileusis (SILK™) using the ELITA™ femtosecond laser system for correction of myopic and astigmatic refractive errors. Clin Ophthalmol. 2023;17:3761–3773. doi:10.2147/OPTH.S432459
2. Alpins N. [Letter to the Editor] Safety and effectiveness of smooth incision lenticular keratomileusis (SILK™) using the ELITA™ femtosecond laser system for correction of myopic and astigmatic refractive errors. Clin Ophthalmol. 2024;18:1959–1960. doi:10.2147/OPTH.S481676
3. Eydelman MB, Drum B, Holladay J, et al. Standardized analyses of correction of astigmatism by laser systems that reshape the cornea. J Refract Surg. 2006;22(1):81–95. doi:10.3928/1081-597X-20060101-16
4. Zhang J, Wang Y, Wu W, Xu L, Li X, Dou R. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. BMC Ophthalmol. 2015;15(1):8. doi:10.1186/1471-2415-15-8
5. Jabbarvand M, Khodaparast M, Moravvej Z, et al. Vector analysis of moderate to high myopic astigmatism after small-incision lenticule extraction (SMILE): 12-month follow-up. Eur J Ophthalmol. 2022;32(6):3312–3320. doi:10.1177/11206721221080821
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