International Multicenter, Prospective, Myopic Femtosecond-Laser Assisted Myopic Lasik, Customized By Automated Ray-Tracing Calculation Of Low And High Order Aberrations: A Post-Market Study.
Published 2023 - 41st Congress of the ESCRS
Reference: FP15.11 | Type: Free paper | DOI: 10.82333/8en7-d683
Authors: Anastasios John John Kanellopoulos* 1 , Matthias Maus 2 , Chandra Bala 3 , Ramin Khoramnia 4
1Ophthalmology,LaserVision Ambulatory Eye Surgery Unit,Athens,Greece;Ophthalmology,NYU Med School,New York,United States, 2Ophthalmology,Sehkraft Augenzentrum,Koln,Germany, 3Ophthalmology,PersonalEyes,Sydney,Australia, 4Department of Ophthalmology,University of Heidelberg,Heidelberg,Germany
Purpose
To assess the safety and efficacy of a novel, customized ablation treatment (InnovEyes) to correct myopia and myopic astigmatism with femtosecond-assisted laser in-situ keratomileusis (Femto LASIK).
Setting
Laservision.gr Clinical and Research Institute, Athens, Greece.
NYU Medical School, Department of Ophthalmology, New York City, NY, USA.
Sehkraft Augenzentrum, Köln, Germany
Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany
Methods
In this prospective multicenter study, 113 patients (225 eyes) with preoperative myopia less than -9.0 D and astigmatism 0 to -4.0 D (based on InnovEyes calculated refraction) underwent wavefront, tomography, and biometry assessment using a single diagnostic device (InnovEyes Sightmap). These data were imported and calculated automatically by the InnovEyes algorithm software, and used unmodified for customized optimization of low and high order aberrations treated by the EX500 excimer ablation profile. Visual acuity, refractive error, higher-order aberrations, and patient satisfaction were evaluated over 3 months
Results
Mean preoperative manifest refraction spherical equivalent (MRSE) was -3.38±1.76 D. At Month 3, uncorrected distance visual acuity (UDVA) was 20/20 or better in 98.1% of eyes, and in 76.4% of eyes was same or better than the preoperative corrected distance visual acuity (CDVA); 35.8% of eyes gained ≥1 line of CDVA. MRSE was within ±0.5 D in 92.0% of eyes. Additionally, 96.2% of eyes had no change in Higher Order Aberrations (HOAs) and 99.1% of patients reported to be highly satisfied with the results.
Conclusions
Customized by ray-tracing Femto LASIK with this novel platform appeared safe and effective in correcting myopic astigmatism and also achieved a significant percentage of eyes gaining lines of vision, likely by addressing high order aberrations, along with a consistently high level of patient satisfaction