International Multicenter, Myopic and Myopic Astigmatism Femto LASIK, Customized by Automated Ray-Tracing Ablation Profile Calculation: A Postmarket Study

Abstract

Purpose

To assess the safety and efficacy of a customized ablation treatment (InnovEyes) to correct myopia and myopic astigmatism with femtosecond laser-assisted in situ keratomileusis (Femto LASIK).

Patients and Methods

In this prospective, nonrandomized, multicenter study, 113 patients (225 eyes) with preoperative myopia less than −9.0 diopters (D) and astigmatism 0 to −4.0 D (based on InnovEyes refraction) underwent wavefront, tomography, and biometry assessment using a single diagnostic device (InnovEyes sightmap). These data were imported and used unmodified by the InnovEyes algorithm to automatically calculate and optimize correction of lower- and higher‑order aberrations (HOAs) treated by the EX500 ablation profile. Visual acuity, refractive error, HOAs, and patient satisfaction were evaluated over 3 months.

Results

A total of 106 patients (212 eyes) completed the study and were included in the analysis. Mean preoperative manifest refraction spherical equivalent (MRSE) was −3.38±1.76 D. At Month 3, uncorrected distance visual acuity was 20/20 or better in 208/212 (98.1%) eyes, and it was the same as, or better than, the preoperative best-corrected distance visual acuity (CDVA) in 162/212 (76.4%) eyes; 76/212 (35.8%) eyes gained ≥1 line of CDVA. MRSE was within ±0.5 D in 195/212 (92.0%) eyes. Additionally, 201/209 (96.2%) eyes had no change (defined as a change between −0.1 μm and 0.1 μm, inclusive) in HOAs, and 105/106 (99.1%) patients reported to be satisfied with the results.

Conclusion

Customizing ray-tracing Femto LASIK with this platform appeared safe and effective in correcting myopic astigmatism and also achieved a significant percentage of eyes gaining lines of vision, potentially by addressing HOAs, along with a consistently high level of patient satisfaction.

Keywords:

• myopic astigmatism
• higher-order aberrations
• manifest refraction spherical equivalent
• corrected distance visual acuity

Abbreviations

AE, adverse event; ANSI, American National Standards Institute; CDVA, corrected distance visual acuity; D, diopter; ETDRS, Early Treatment Diabetic Retinopathy Study; FAS, full analysis set; FDA, US Food and Drug Administration; Femto LASIK, femtosecond-assisted laser in situ keratomileusis; HOAs, higher-order aberrations; ISO, International Organization for Standardization; LASIK, laser-assisted in situ keratomileusis; logMAR, logarithm of the minimum angle of resolution; MRSE, manifest refraction spherical equivalent; PROWL, Patient‑Reported Outcomes With LASIK; RMSh, root mean square of higher-order aberrations; SE, spherical equivalent; UDVA, uncorrected distance visual acuity.

Data Sharing Statement

The data used and analyzed during the current study are not publicly available and will not be shared due to commercial interests. For additional detail, please contact the study sponsor via https://drks.de/search/en/trial/DRKS00020388.

Acknowledgments

The authors received editorial assistance in the preparation of the manuscript from Chameleon Communications International (London, UK), which was funded by Alcon Vision, LLC and conducted in accordance with Good Publication Practice guidelines.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

MM has received consulting fees from WaveLight (a subsidiary of Alcon; Erlangen, Germany) and equipment or other services from Alcon and is a board member of the Refractive Surgery Alliance. CB has received grants, consulting fees, and fees for education events from Alcon; grants from Johnson & Johnson (Irvine, CA, USA); and consulting fees from Hoya (Tokyo, Japan). CH, SL, and MEJ are employees of, and stockholders in, Alcon. RK has received grants, lecture fees, and travel support from Alcon and Johnson & Johnson; has received lecture fees from Carl Zeiss (Oberkochen, Germany), Heidelberg Engineering (Heidelberg, Germany), Bausch + Lomb (Bridgewater, NJ, USA), and Oculus (Wetzlar, Germany); and is an unpaid board member of DGII. All authors report no other conflicts of interest in this study.

Additional information

Funding

Funding support for this manuscript was provided to authors by Alcon Vision, LLC (Fort Worth, TX, USA). This work was sponsored by Alcon Vision, LLC. The sponsors participated in the study design; collection, analysis, and interpretation of data; writing the report; decision to submit the report for publication; and preparation, review, and approval of the manuscript. This study was registered with the German Clinical Trials Register (www.drks.de/drks_web/; ID: DRKS00020388).