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Identifying a Clinically Meaningful Threshold for Change in Uveitic Macular Edema Evaluated by Optical Coherence Tomography - 21/11/11

Doi : 10.1016/j.ajo.2011.05.028 
Elizabeth A. Sugar a, b, c, , Douglas A. Jabs a, d, e, Michael M. Altaweel f, Sue Lightman g, Nisha Acharya h, Albert T. Vitale i, Jennifer E. Thorne a, j

Multicenter Uveitis Steroid Treatment (MUST) Trial Research Group

a Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland 
b Department of Biostatistics, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland 
c Division of Biostatistics and Bioinformatics, The Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland 
d Department of Ophthalmology, Mount Sinai School of Medicine, New York, New York 
e Department of Medicine, Mount Sinai School of Medicine, New York, New York 
f Department of Ophthalmology, the University of Wisconsin, Madison, Wisconsin 
g Institute of Ophthalmology, University College London, London, United Kingdom 
h Department of Ophthalmology, Proctor Foundation, University of California, San Francisco, San Francisco, California 
i Department of Ophthalmology, Moran Eye Institute, University of Utah, Salt Lake City, Utah 
j Department of Ophthalmology, Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 

Inquiries to Elizabeth A. Sugar, Departments of Epidemiology and Biostatistics, Bloomberg School of Public Health, The Johns Hopkins University, 615 North Wolfe Street, Suite W5010, Baltimore, MD 21205

Resumen

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.

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 Supplemental Material available at AJO.com


© 2011  Elsevier Inc. Reservados todos los derechos.
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Vol 152 - N° 6

P. 1044 - décembre 2011 Regresar al número
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