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• W2020397834 abstract "Purpose To examine the risk of serious visual loss in contemporary LASIK. Design Retrospective, noncomparative, consecutive case series combined with a structured literature review and comparison with historical controls. Participants One thousand consecutive cases of LASIK performed from January 2000 to January 2004 by 1 surgeon. One thousand nine hundred eighty-two cases with 6-month review data in postmillennial Food and Drug Administration (FDA) trials of LASIK for myopia and astigmatism and 5203 patients with 6 month review data in similar premillennial FDA trials. Methods LASIK was performed with the Hansatome microkeratome and a VISX Star (S2, S3, or S4) laser. There were 899 myopic treatments (spherical equivalent ≤−10.5 diopters [D]; average −4.2 D; standard deviations [SD] D = 1.9 D; astigmatism ≤4.75 D), 87 hyperopic treatments (spherical equivalent ≤+4.25 D; average +2.4 D; SD = 0.9 D; astigmatism ≤3.5 D), and 14 treatments for mixed astigmatism (≤4.5 D). Outcome data were obtained from a review of case notes and compared with historical data from FDA trials. Main Outcome Measures Best-spectacle corrected visual acuity (BSCVA) preoperatively and at final review was compared in our case series with reference to the United Kingdom driving standard (BSCVA≥20/30). Subsidiary outcome measures included duration of follow-up, intraoperative, and postoperative complication rates. Six-month postoperative data on standard safety criteria (numbers of patients losing ≥2 lines BSCVA, BSCVA <20/40, and final BSCVA <20/25 for patients with preoperative BSCVA ≥20/20) were examined in FDA trials. Results In our clinical series, no case with a preoperative BSCVA of 20/20 or better had a final BSCVA of <20/30 at final review (97.5% confidence interval [CI], 0%–0.37%); 4 eyes had a BSCVA <20/25 (0.41%; 95%CI, 0.11%–1.02%). The median interval between surgery and final review was 2 months (range, 1–45 months). In FDA studies recruiting pre-2000, 1.4% of patients lost ≥2 lines of BSCVA versus 0.6% in postmillennial studies (P = 0.005); 0.45% of patients in premillennial studies lost BSCVA to <20/40 compared with no patients in postmillennial studies (P = 0.001); and 1.68% of patients in premillennial studies with a preoperative BSCVA ≥20/20 had a postoperative BSCVA <20/25 compared with 0.16% in postmillennial studies (P≤0.001). Conclusions Compared with premillennial results, the risk of visual loss is significantly reduced in contemporary LASIK. To examine the risk of serious visual loss in contemporary LASIK. Retrospective, noncomparative, consecutive case series combined with a structured literature review and comparison with historical controls. One thousand consecutive cases of LASIK performed from January 2000 to January 2004 by 1 surgeon. One thousand nine hundred eighty-two cases with 6-month review data in postmillennial Food and Drug Administration (FDA) trials of LASIK for myopia and astigmatism and 5203 patients with 6 month review data in similar premillennial FDA trials. LASIK was performed with the Hansatome microkeratome and a VISX Star (S2, S3, or S4) laser. There were 899 myopic treatments (spherical equivalent ≤−10.5 diopters [D]; average −4.2 D; standard deviations [SD] D = 1.9 D; astigmatism ≤4.75 D), 87 hyperopic treatments (spherical equivalent ≤+4.25 D; average +2.4 D; SD = 0.9 D; astigmatism ≤3.5 D), and 14 treatments for mixed astigmatism (≤4.5 D). Outcome data were obtained from a review of case notes and compared with historical data from FDA trials. Best-spectacle corrected visual acuity (BSCVA) preoperatively and at final review was compared in our case series with reference to the United Kingdom driving standard (BSCVA≥20/30). Subsidiary outcome measures included duration of follow-up, intraoperative, and postoperative complication rates. Six-month postoperative data on standard safety criteria (numbers of patients losing ≥2 lines BSCVA, BSCVA <20/40, and final BSCVA <20/25 for patients with preoperative BSCVA ≥20/20) were examined in FDA trials. In our clinical series, no case with a preoperative BSCVA of 20/20 or better had a final BSCVA of <20/30 at final review (97.5% confidence interval [CI], 0%–0.37%); 4 eyes had a BSCVA <20/25 (0.41%; 95%CI, 0.11%–1.02%). The median interval between surgery and final review was 2 months (range, 1–45 months). In FDA studies recruiting pre-2000, 1.4% of patients lost ≥2 lines of BSCVA versus 0.6% in postmillennial studies (P = 0.005); 0.45% of patients in premillennial studies lost BSCVA to <20/40 compared with no patients in postmillennial studies (P = 0.001); and 1.68% of patients in premillennial studies with a preoperative BSCVA ≥20/20 had a postoperative BSCVA <20/25 compared with 0.16% in postmillennial studies (P≤0.001). Compared with premillennial results, the risk of visual loss is significantly reduced in contemporary LASIK." @default.
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• W2020397834 date "2005-08-01" @default.
• W2020397834 modified "2023-09-27" @default.
• W2020397834 title "Improved Safety in Contemporary LASIK" @default.
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• W2020397834 doi "https://doi.org/10.1016/j.ophtha.2005.02.012" @default.
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