4.6 Article

Identifying a Clinically Meaningful Threshold for Change in Uveitic Macular Edema Evaluated by Optical Coherence Tomography

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AMERICAN JOURNAL OF OPHTHALMOLOGY
卷 152, 期 6, 页码 1044-1052

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ELSEVIER SCIENCE INC
DOI: 10.1016/j.ajo.2011.05.028

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资金

  1. National Eye Institute, National Institutes of Health, Bethesda, Maryland [U10 EY 014655]
  2. Johns Hopkins University Bloomberg School of Public Health [U10 EY 014660]
  3. University of Wisconsin, Madison, School of Medicine [U10 EY 014656]
  4. Abbott Laboratories
  5. Alcon Laboratories
  6. Allergan Pharmaceutical Corporation
  7. Applied Genetic Technologies Corporation
  8. Corcep Therapeutics
  9. Genentech, Inc
  10. Genzyme Corporation
  11. GlaxoSmithKline
  12. Novartis Pharmaceuticals Corporation
  13. Roche Pharmaceuticals
  14. Bausch Lomb
  15. ACIONT, Inc.

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PURPOSE: To identify a clinically meaningful threshold for change in retinal thickness measured by optical coherence tomography for patients with uveitic macular edema using correlation with change in visual acuity. DESIGN: Cross-sectional and longitudinal study. METHODS: One hundred twenty-eight eyes (101 individuals) with macular edema enrolled in the Multicenter Uveitis Steroid Treatment (MUST) trial. At enrollment and after 6 months of follow-up, retinal thickness was measured at the central subfield with time-domain optical coherence tomography and visual acuity was measured with logarithmic (Early Treatment Diabetic Retinopathy Study) visual acuity charts. Participants were classified as having macular edema if the retinal thickness was 260 mu m or more. RESULTS: A threshold for change in retinal center subfield thickness of 20% balanced the percentage of false positives and false negatives for predicting more than a 10-letter change in visual acuity with a sensitivity of 77% and a specificity of 75%. The results were similar for more than 5-letter changes and for 15-letter or more changes. Those with a 20% or more reduction in retinal thickness had a mean 11.0-letter improvement (95% confidence interval, 7.7 to 14.3) as compared with a -0.4-letter change (95% confidence interval, -4.1 to 3.3) in visual acuity for those without a 20% reduction (P < .01). CONCLUSIONS: In addition to being above the level of measurement uncertainty, a 20% change in retinal thickness in patients with macular edema seems to be optimal for clinically important changes in visual acuity and may be considered as an outcome for clinical trials of treatments for uveitic macular edema. (Am J Ophthalmol 2011;152:1044-1052. (C) 2011 by Elsevier Inc. All rights reserved.)

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