Myopic And Astigmatic Laser In-Situ Keratomileusis Using A New Ray Tracing-Based Treatment Algorithm With An Individualized Ablation Profile: The U. S. F D A Clinical Trial

To evaluate safety and efficacy of ray tracing-based LASIK surgery for the correction of myopia with and without astigmatism in a statistically significant multicenter cohort with 12 month outcomes.

U.S. FDA Multicenter Trial in 9 Study Centers

In this prospective, single-arm, multicenter, U.S. FDA study, patients were enrolled with ≥21 years of age and myopia of ≤-11.0 D, with or without astigmatism ≤-4.5 D. For each eye, a virtual 3D model and individualized ablation profile was developed using data collected from the InnovEyes Sightmap and processed by the WaveLight Plus ray-tracing algorithm. Efficacy endpoints included the percentage of eyes achieving MRSE within 1.0 D of emmetropia and UDVA of 20/40 or better at refractive stability. Safety endpoints included the percentages of eyes that lost ≥2 lines CDVA at refractive stability versus preoperative CDVA and non-flap related ocular serious adverse events (SAE).

Of the 168 patients (336 eyes) enrolled, 161 patients (322 eyes) completed the study. Refractive stability was achieved at 3 months. At 3 months postop, 98.5% of eyes had MRSE within 1.0 D of target and 92% were within 0.5 D. 100% of eyes achieved UDVA of 20/40 or better, 92.3% of eyes achieved 20/20 or better, 66.9% of eyes 20/16 or better, and 20.7% of eyes 20/12.5 or better. No eyes lost ≥2 lines of CDVA, and there were no new safety signals at 3 months. No ocular SAEs or non-ocular adverse device effects were reported.

Ray tracing-guided LASIK with and individualized ablation profile was safe and effective for correcting myopia with and without astigmatism, producing good, stable visual outcomes.