Identifying a clinically meaningful threshold for change in uveitic macular edema evaluated by optical coherence tomography

Am J Ophthalmol. 2011 Dec;152(6):1044-1052.e5. doi: 10.1016/j.ajo.2011.05.028. Epub 2011 Sep 8.

Abstract

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 μm 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.

Trial registration: ClinicalTrials.gov NCT00132691.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cross-Sectional Studies
  • False Positive Reactions
  • Female
  • Fluocinolone Acetonide / administration & dosage
  • Glucocorticoids / administration & dosage
  • Humans
  • Longitudinal Studies
  • Macular Edema / drug therapy
  • Macular Edema / physiopathology*
  • Male
  • Middle Aged
  • Predictive Value of Tests
  • Prospective Studies
  • Reproducibility of Results
  • Retina / pathology*
  • Sensitivity and Specificity
  • Sensory Thresholds / physiology
  • Tomography, Optical Coherence*
  • Uveitis / drug therapy
  • Uveitis / physiopathology*
  • Visual Acuity / physiology*

Substances

  • Glucocorticoids
  • Fluocinolone Acetonide

Associated data

  • ClinicalTrials.gov/NCT00132691