Analysis and Causation of All Inaccurate Outcomes After WaveLight Contoura LASIK with LYRA Protocol

PURPOSE: This study analyzes every eye that had an outcome greater than 0.25D of sphere or astigmatism from planned goal after treatment with WaveLight Contoura with LYRA Protocol. METHODS: The study included 266 consecutive eyes treated with LASIK Contoura using the LYRA Protocol. All LASIK procedures were performed on the WaveLight EX500 excimer laser. Flaps were created with either the Alcon WaveLight FS200 femtosecond laser or the Moria M2 microkeratome. Eyes that were off by >0.25 diopters (D) sphere or cylinder from the targeted goal within 3 months after surgery were identified and analyzed for cause. Topographical, higher-order aberration, and epithelial maps were created. RESULTS: Causes for inaccurate outcomes were biomechanical corneal change from LASK flap creation (9.78% of total eyes), pre-operative epithelial compensation of corneal higher-order aberration (4.1% of total eyes), changes to lamellar corneal tension from laser ablation causing a hyperopic shift (1.9% of total eyes), epithelial thickening over the ablation area post-operatively causing a refractive change (1.5% of total eyes), and posterior astigmatism (0.75%). CONCLUSION: The causes of the majority of inaccurate outcomes have not been properly defined and must be incorporated into further improving outcomes. Current and planned advances in technology do not address the majority of these causes.