Received 23 December 2004; accepted 4 February 2005. published online 13 June 2005.
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.
Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom.
Correspondence to Dr Stephanie L. Watson, Department of Ophthalmology, The Prince of Wales Hospital at the University of New South Wales, Randwick, NSW 2031, Australia.
Manuscript no. 2004-443.
Dr Watson is supported by a National Health and Medical Research Council (Canberra, Australia) Gustav Nossal Scholarship.
Two of the authors (SLW, BDSA) derive a private practice income from refractive surgery but have no other financial interest in this topic or the article. Dr Bunce has no financial interest in the subject matter.
ABSTRACT