Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems.  

METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents.  

RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual changes in pre- to postoperative subjective symptoms.  

CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.