Dr. Michael Grimmett, FDA consultant, questioning representative of laser manufacturer during review of clinical trials for wavefront-guided custom LASIK: " I just had an observation and would like to hear if you have a comment. You may have none. There may be no answer. I found it curious that despite a very comprehensive analysis and sophisticated technology, that the patients that were unsatisfied or extremely unsatisfied approximated 9 percent."
In spite of the marketing hype, there are substantial barriers to achieving better vision from LASIK than with glasses or contact lenses. FDA-required clinical trials of custom wavefront LASIK demonstrate that patients' quality of vision is worse after LASIK, even with the latest custom wavefront technology.
From the FDA website:
Q: How does wavefront (custom) LASIK compare to conventional (older technology) LASIK?
A: Wavefront adds an automatic measurement of more subtle distortions (called higher order aberrations) than just nearsightedness, farsightedness, and astigmatism corrected by conventional LASIK. However, these "higher order aberrations" account for only a small amount (probably no more than 10%) of the total refractive error of the average person's eye. Conventional LASIK increases higher order aberrations. Although wavefront-guided treatments attempt to eliminate higher order aberrations, results from the clinical studies have shown that the average aberrations still increase, but less than they do after conventional LASIK. In a few studies comparing wavefront-guided LASIK to conventional LASIK, a slightly larger percentage of subjects treated with wavefront LASIK achieved 20/20 vision without glasses or contact lenses compared to subjects treated with conventional LASIK... Source
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