BLOG: LASIK outcomes – When in doubt ask the patient

ByJohn A. Hovanesian, MD, FACS

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.

Well-done studies have shown repeatedly that LASIK has a safety record (in terms of frequency of major complications) about four times greater than contact lens wear. Quality of vision and capacity to correct higher-order aberrations are far better with LASIK. Cost of LASIK, in the long run, competes very favorably with contact lenses, and there is no issue with patient compliance after initial healing. Most importantly, people’s lives are vastly improved by LASIK, and they genuinely appreciate what we do for them. These facts are sure to come out of the FDA adding a subjective component to its evaluation of LASIK surgery.

David Carey, one of my favorite teachers and my residency director, once taught me, “If you look very carefully outside the eyeball you’re examining, there’s a whole patient sitting in the chair, and occasionally you should talk to him about what he’s feeling.” It’s nice to see the FDA is finally doing this.

Disclosure: Hovanesian has no relevant financial disclosures.