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

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.

Copyright © 2011 Elsevier Inc. All rights reserved.

Figures

Figure 1

Plot of the percentage change in retinal thickness at the central subfield measured by optical coherence tomography (OCT) versus the change in visual acuity (VA) from enrollment to six months in eyes with uveitic macular edema.

Figure 2

Plot of the sensitivities and specificities associated with different thresholds of percentage change in retinal thickness (measured by optical coherence tomography, OCT, at the central subfield) for identifying a greater than 10 letter increase in visual acuity in eyes with uveitic macular edema.