PubMed · 11366596
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1999-07-23. Corruption case.. https://pubmed.ncbi.nlm.nih.gov/11366596/
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OBJECTIVE: This document describes laser in situ keratomileusis (LASIK) for myopia and astigmatism and examines the evidence to answer key questions about the efficacy and safety of the procedure. METHODS: A literature search conducted for the years 1968 to 2000 retrieved 486 citations and an update search conducted in June 2001 yielded an additional 243 articles. The panel members reviewed 160 of these articles and selected 47 for the panel methodologist to review and rate according to the strength of evidence. A Level I rating is assigned to properly conducted, well-designed, randomized clinical trials; a Level II rating is assigned to well-designed cohort and case-control studies; and a Level III rating is assigned to case series and poorly designed prospective and retrospective studies, including case-control studies. RESULTS: The assessment describes randomized controlled trials published in 1997 or later (Level I evidence) and more recent comparative and noncomparative case series (Level II and Level III evidence), focusing on results for safety and effectiveness. It is difficult to extrapolate results from these studies that are comparable to current practices with the most recent generation lasers because of the rapid evolution of LASIK technology and techniques. It is also difficult to compare studies because of variations in the range of preoperative myopia, follow-up periods, lasers, nomograms, microkeratomes and techniques, the time frame of the study, and the investigators' experience. CONCLUSIONS: For low to moderate myopia, results from studies in the literature have shown that LASIK is effective and predictable in terms of obtaining very good to excellent uncorrected visual acuity and that it is safe in terms of minimal loss of visual acuity. For moderate to high myopia (>6.0 D), the results are more variable, given the wide range of preoperative myopia. The results are similar for treated eyes with mild to moderate degrees of astigmatism (<2.0 D). Serious adverse complications leading to significant permanent visual loss such as infections and corneal ectasia probably occur rarely in LASIK procedures; however, side effects such as dry eyes, night time starbursts, and reduced contrast sensitivity occur relatively frequently. There were insufficient data in prospective, comparative trials to describe the relative advantages and disadvantages of different lasers or nomograms.
In December 2000, President Clinton signed legislation establishing the National Institute of Biomedical Imaging and Bioengineering (NIBIB). This action was the result of a multidecade effort of the biomedical imaging and engineering communities to gain increased recognition for biomedical imaging and engineering research within the National Institutes of Health and to enhance the impact of these disciplines on the health and well-being of people worldwide. Beginning in January 2001, several activities were initiated to form NIBIB into a real asset for researchers in biomedical imaging and engineering. These activities reflect a recognition that research in biomedical imaging and bioengineering has the potential of positively influencing research in many other biomedical disciplines, as well as directly affecting the welfare of people everywhere. This potential impact is discussed in this report, together with the history and present status of the formation of NIBIB.
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