FDA clinical trials show ~20% complication rate six months after LASIK
May 3rd, 2008
Cornea. 2007 Apr;26(3):246-54.
Outcomes of LASIK for myopia with FDA-approved lasers.
Bailey MD, Zadnik K.
The Ohio State University College of Optometry, Columbus, OH 43210 , USA. mbailey@optometry.osu.edu
PURPOSE: To report expected outcomes of laser in situ keratomileusis (LASIK) for myopia and myopic astigmatism from existing US Food and Drug Administration (FDA) data.
METHODS: Data from Summaries of Safety and Effectiveness for each of the 12 lasers approved by the FDA for LASIK for myopia or myopic astigmatism between 1998 and 2004 were recorded from the FDA Web site. The Cochran-Armitage test for trend was used to determine whether improvements in outcomes occurred with laser technology changes.
RESULTS: For all patients, there was a statistically significant trend toward improvement with improved laser technology in the proportion of patients with uncorrected visual acuity (UCVA) of 20/20 or better, UCVA of 20/40 or better, results within +/-0.50 D of intended correction, results within +/-1.00 D of the intended correction, and night vision symptoms (all P < 0.0002). Because there were preoperative differences across laser types, subgroup analyses were also completed. The results for subgroup analyses (high myopia, low to moderate myopia, spherical myopia, and myopic astigmatism) for visual acuity and refractive error outcomes were similar to results for analyses for all groups combined. Conversely, there was no difference across laser types in the proportion of patients who experienced dry eye symptoms or for the proportion of patients with low to moderate myopia who experienced night vision symptoms that were worse or significantly worse than before LASIK.
CONCLUSIONS: LASIK provides excellent visual acuity and refractive error outcomes. Night vision and dryness symptoms still occur in a significant proportion of patients. Future studies should seek to determine whether additional changes in technology, patient selection criteria, or postoperative treatment could reduce or eliminate these symptoms.
From the full text: “In [FDA] studies, ~15% of patients experienced night vision symptoms that were worse or significantly worse than preoperative night vision symptoms. Approximately 20% of patients experienced dryness symptoms that were worse or significantly worse than preoperative dryness.” View complication table
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