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

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.