January 28, 2015
It’s so pleasing to see that the U.S. Food and Drug Administration is increasingly evaluating patient-reported outcomes to assess the validity of a technology. The shift for the FDA from objective to subjective evaluation has happened because subtle advances happen in drugs and devices that can be difficult to fully assess with objective measures. Further, our electronic capability for surveying patients has only improved with time, as the majority of adult Americans now carry a computer (smartphone) in their pockets.
Correcting a patient to 20/happy, regardless of Snellen acuity and refraction, has long been the goal of most seasoned refractive surgeons, and we know that the vast majority of our patients are quite content with their results. The rare few whose complications or singular challenges have limited their satisfaction have all too vocally influenced both the FDA and public perception about the value of this procedure.