Stability, Safety, and Efficacy of WaveLight Plus InnovEyes Ray-Tracing-Guided LASIK in Myopia and Myopic Astigmatism: A One-Year Prospective Study.

Objective

To evaluate the efficacy, safety, refractive accuracy, and stability of WaveLight Plus InnovEyes ray-tracing-guided LASIK (WL Plus LASIK) in myopia and myopic astigmatism.

Design

Prospective, non-randomized interventional study. SUBJECTS,

Participants

AND/OR CONTROLS A total of 800 eyes of 400 patients with myopia or myopic astigmatism and a predefined subgroup of 300 eyes with preoperative cylinder ≥1.50 D was included. METHODS,

Intervention

OR TESTING All eyes underwent femtosecond LASIK using WaveLight Plus InnovEyes ray-tracing-guided treatment planning. Multimodal biometric, tomographic, and wavefront data were integrated to generate individualized ablation profiles by reconciling the wavefront-derived refraction with the cycloplegia-verified manifest refraction. Patients were followed for 12 months. Astigmatic outcomes in the entire cohort and high-cylinder subgroup were assessed using the Alpins vector method. MAIN OUTCOME MEASURES Uncorrected distance visual acuity (UDVA), spherical equivalent (SE) accuracy, refractive stability, safety index and vector parameters including target-induced astigmatism (TIA), surgically induced astigmatism (SIA), correction index (CI), difference vector (DV) and angle of error (AoE).

Results

At 12 months, 100% of eyes achieved UDVA ≥20/20 and 68% achieved ≥20/16. Mean postoperative UDVA was -0.07 ± 0.05 logMAR, with an efficacy index of 1.17 ± 0.12. The safety index was 1.17 ± 0.12, with no eyes losing ≥2 lines of CDVA. Refractive accuracy was high, with 96.5% of eyes within ±0.50 D and 100% within ±1.00 D of target SE. Mean postoperative SE was -0.08 ± 0.24 D, with excellent predictability (R² = 0.99). Refractive stability was maintained, with only 0.38% of eyes showing >0.50 D change between 1 and 12 months. Residual astigmatism was ≤0.50 D in 95.2% of eyes overall and 91.7% in the high-cylinder subgroup. Vector analysis demonstrated mild undercorrection (mean CI 0.94 overall, 0.93 in subgroup), low residual error (mean DV 0.15 D overall, 0.21 D in subgroup), and high axis accuracy, with 85% of subgroup eyes within ±5°.

Conclusions

WL Plus LASIK demonstrates excellent efficacy, safety, refractive accuracy and stability at one year. The platform provides precise astigmatic correction with minimal residual error and high axis alignment, including in eyes with higher astigmatism, indicating that ray-tracing-guided LASIK is an effective and predictable option for the correction of myopia and myopic astigmatism.