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


CONCLUSIONS
We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.
Wachler
Brian S Boxer
BS
Boxer Wachler Vision Institute, Beverly Hills, CA 90210, USA. bbw@boxerwachler.com
Hiatt
James A
JA
D002986:Clinical Trials as Topic; D015350:Contrast Sensitivity; D019781:Corneal Topography; D018795:Device Approval; D004867:Equipment Design; D006801:Humans; D020731:Keratomileusis, Laser In Situ / Q000009:adverse effects / Q000295:instrumentation*; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D017060:Patient Satisfaction; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*