Myopic and Astigmatic Laser in situ Keratomileusis Using a Ray Tracing−Based Treatment Algorithm with a Personalized Ablation Profile

Purpose: Evaluate the safety and efficacy of ray tracing‒based LASIK surgery to correct myopia in eyes with and without astigmatism. Patients and Methods: This prospective study included adults with myopia up to − 10.00 D, with or without astigmatism (NCT04219891). For each eye, a 3D virtual model and personalized ablation profile were developed using data from InnovEyes™ Sightmap and ray-tracing algorithm, followed by a wavelight plus LASIK treatment. Efficacy endpoints included percentage of eyes achieving manifest refraction spherical equivalent (MRSE) within 1.00 and 0.50 D of emmetropia at refractive stability and uncorrected distance visual acuity (UDVA) assessments. Follow-up was up to 12 months. Safety endpoints included percentage of eyes that lost ≥ 2 lines corrected distance visual acuity (CDVA) at refractive stability versus preoperative CDVA and non‒flap-related ocular serious adverse events (SAEs). Mean optical aberrations were assessed. Dry eye symptoms were evaluated using ocular surface disease index scores. Patient-reported outcomes were assessed using Patient-Reported Outcomes With LASIK questionnaire. Results: A total of 163 patients (326 eyes) completed the study. Refractive stability was achieved at 3 months; during a 1- to 3-month interval, 99.4% of eyes had ≤ 1.00 D change in MRSE. MRSE within 0.50 and 1.00 D of emmetropia was achieved in 92.0% and 98.5% of eyes. At 12 months, 94.4% of eyes achieved UDVA of 20/20 or better. No eyes lost ≥ 2 lines of CDVA; no ocular SAEs or non-ocular adverse device effects were reported. Slight increase in coma (0.086 μm) and decrease in spherical aberration (− 0.030 μm) were reported at 12 months. Dry eye symptoms improved after procedure (preoperative, 14.90± 13.07; 12 months, 7.69± 8.12). Postoperatively, 98% of patients reported being very/completely satisfied with their vision. Conclusion: Ray tracing‒guided LASIK treatment was safe and effective for correcting myopia in individuals with and without astigmatism, producing stable visual outcomes and high satisfaction.