@article{54ce1b442be241c2965a4a66e14b7011,
title = "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.",
author = "Sugar, {Elizabeth A.} and Jabs, {Douglas A.} and Altaweel, {Michael M.} and Sue Lightman and Nisha Acharya and Vitale, {Albert T.} and Thorne, {Jennifer E.}",
note = "Funding Information: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Publication of this article was supported by cooperative agreements from the National Eye Institute, National Institutes of Health , Bethesda, Maryland, to Mount Sinai School of Medicine ( U10 EY 014655 ), The Johns Hopkins University Bloomberg School of Public Health ( U10 EY 014660 ), and the University of Wisconsin, Madison, School of Medicine ( U10 EY 014656 ). Bausch & Lomb provided support to the study in the form of donation of a limited number of fluocinolone implants for patients randomized to implant therapy who were uninsured or otherwise unable to pay for the implants. Dr Thorne is the recipient of the Research to Prevent Blindness Sybill Harrington Special Scholars Award. Dr Jabs has received consulting fees from Abbott Laboratories, Alcon Laboratories, Allergan Pharmaceutical Corporation, Applied Genetic Technologies Corporation, Corcep Therapeutics, Genentech, Inc, Genzyme Corporation, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, and Roche Pharmaceuticals. Dr Altaweel has received from Pfizer, Regeneron, and GlaxoSmithKline. Dr Lightman has received consulting fees from Allergan Pharmaceutical Corporation, Abbott Laboratories Ltd, Bausch & Lomb, Genactis Ltd, GlaxoSmithKline, Immunocore Ltd, Schering Plough, Virtuoso Healthcare Communications, and The Wellcome Trust and honoraria from GlaxoSmithKline. Dr Vitale has received consulting fees from Bausch & Lomb and ACIONT, Inc. Dr Thorne has received consulting fees from Allergan Pharmaceutical Corporation. Drs Sugar and Acharya indicate no financial conflicts of interest. Involved in Design of study (E.A.S., D.A.J., M.M.A., J.E.T.); Conduct of study (E.A.S., D.A.J., M.M.A., J.E.T.); Collection of data (E.A.S., M.M.A., S.L., N.A., A.T.V.); Management of data (E.A.S.); Analysis of data (E.A.S.); Interpretation of data (E.A.S., D.A.J., M.M.A., S.L., N.A., A.T.V., J.E.T.); Preparation of manuscript (E.A.S.); Review of manuscript (E.A.S., D.A.J., M.M.A., S.L., N.A., A.T.V., J.E.T.); and Approval of manuscript (E.A.S., D.A.J., M.M.A., S.L., N.A., A.T.V., J.E.T.). The study has been registered at ClinicalTrials.gov (identifier NCT00132691 ) and was approved by the governing institutional review boards of all participating institutions. ",
year = "2011",
month = dec,
doi = "10.1016/j.ajo.2011.05.028",
language = "English (US)",
volume = "152",
pages = "1044--1052.e5",
journal = "American journal of ophthalmology",
issn = "0002-9394",
publisher = "Elsevier USA",
number = "6",
}