gms | German Medical Science

Purpose: The automated customized femtosecond laser-assisted in situ keratomileusis (LASIK) procedure wavelight plus (Alcon) uses ray-tracing ablation profile calculation based on ocular wavefront, corneal tomography and ocular biometry data instead of manifest refraction data to determine the ablation profile. The purpose of the study is to evaluate the functional outcomes after the automated customized LASIK treatment in comparison to the wavefront optimized (WFO) LASIK.

Methods: In a prospective, double-blinded, contralateral-eye randomized study 30 patients in total will be enrolled. The wavelight plus Sightmap (Alcon) measurements of corneal tomography, biometry and ocular wavefront were performed preoperatively. One eye per patient was treated with wavelight plus, the fellow eye received WFO LASIK. In this ongoing study, 12 patients were already treated. Manifest refraction, uncorrected (UDVA) and corrected (CDVA) distance visual acuity were assessed both preoperatively and at one month after surgery. So far, the data of the patients who completed the one-month follow up were evaluated. For statistical analysis, the Wilcoxon test for paired variables was used, with p<0.05 considered statistically significant.

Results: The mean (±standard deviation) patient age was 35±6 years. The preoperative UDVA, CDVA, manifest refraction spherical equivalent (MRSE) and refractive cylinder were similar in both study groups, with MRSE of -3.74±1.51 in the wavelight plus and -3.78±1.52 D in the WFO groups. Postoperatively, monocular UDVA was -0.05±0.11 and -0.08±0.11 logMAR, CDVA -0.13±0.07 and -0.14±0.08 logMAR, MRSE 0.09±0.34 and -0.06±0.23 D, refractive cylinder -0.25±0.18 and -0.19±0.21 D after wavelight plus and WFO LASIK, respectively (p>0.05 for all comparisons). All eyes were within ±0.5 D of MRSE, and 88% of eyes in both groups achieved 20/20 UDVA. No eyes lost one or more Snellen lines of CDVA and 25% of the eyes in both groups gained one Snellen line of CDVA.

Conclusions: Both the automated customized ray-tracing based LASIK and the wavefront-optimized LASIK had good efficacy and safety, with comparable outcomes achieved with both treatments. At ESCRS, the three months data of the entire cohort will be presented.