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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 (≤ 4.5D). 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% ). Themedian 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.
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 premier FDA trials. Methods: 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 utcome data were obtained from a review of case notes and compared with historical data from FDA trials. Best 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 status measures included duration of follow-up, intraoperative, and postoperative complication rates. Six-month postoperative data on standard safety criteria (numbers of patients lost <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% final review was 2 months (range, 1- 45 months). In FDA studies recruiting pre-2000 , 1.4% ofpatients 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.