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.