Abstract
BackgroundThe objective of this study is to describe a system for color photograph evaluation in uveitis and report baseline morphologic findings for the Multicenter Uveitis Steroid Treatment (MUST) Trial.Four-hundred seventy-nine eyes of 255 subjects with intermediate, posterior, and panuveitis had stereoscopic color fundus photographs obtained by certified photographers and evaluated by certified graders using standardized procedures to evaluate morphologic characteristics of uveitis. The posterior pole was evaluated for macular edema, vitreoretinal interface abnormalities, and macular pigment disturbance/atrophy; the optic disk was assessed for edema, pallor, or glaucomatous changes. The presence of neovascularization, vascular occlusion, vascular sheathing, and tractional retinal changes was determined. A random subset of 77 images was re-graded to determine the percentage agreement with the original grading on a categorical scale.ResultsAt baseline, 437/479 eyes had images available to grade. Fifty-three eyes were completely ungradable due to media opacity. Common features of intermediate and posterior/panuveitis were epiretinal membrane (134 eyes, 35 %), and chorioretinal lesions (140 eyes, 36 %). Macular edema was seen in 16 %. Optic nerve head and vascular abnormalities were rare. Reproducibility evaluation found exact agreement for the presence of chorioretinal lesions was 78 %, the presence and location of macular edema was 71 %, and the presence of epiretinal membrane was 71 %. Vertical cup-to-disk ratio measurement had intra-class correlation of 0.75.ConclusionsThe MUST system for evaluating stereoscopic color fundus photographs describes the morphology of uveitis and its sequelae, in a standardized manner, is highly reproducible, and allows monitoring of treatment effect and safety evaluation regarding these outcomes in clinical trials.Electronic supplementary materialThe online version of this article (doi:10.1186/s12348-016-0103-2) contains supplementary material, which is available to authorized users.
Highlights
The objective of this study is to describe a system for color photograph evaluation in uveitis and report baseline morphologic findings for the Multicenter Uveitis Steroid Treatment (MUST) Trial
The Multicenter Uveitis Steroid Treatment (MUST) Trial is a randomized, partially masked, multicenter clinical trial comparing the effectiveness and safety of local therapy with the fluocinolone acetonide implant (Bausch & Lomb, Inc.) versus standardized systemic therapy with oral corticosteroids supplemented by immunosuppressive drugs when indicated for patients with severe noninfectious intermediate uveitis, posterior uveitis, or panuveitis [1]
Two-hundred fifty-five subjects were enrolled at 23 clinical sites with images obtained when possible on the 479 eyes with uveitis at baseline
Summary
The objective of this study is to describe a system for color photograph evaluation in uveitis and report baseline morphologic findings for the Multicenter Uveitis Steroid Treatment (MUST) Trial. Four-hundred seventy-nine eyes of 255 subjects with intermediate, posterior, and panuveitis had stereoscopic color fundus photographs obtained by certified photographers and evaluated by certified graders using standardized procedures to evaluate morphologic characteristics of uveitis. The Multicenter Uveitis Steroid Treatment (MUST) Trial is a randomized, partially masked, multicenter clinical trial comparing the effectiveness and safety of local therapy with the fluocinolone acetonide implant (Bausch & Lomb, Inc.) versus standardized systemic therapy with oral corticosteroids supplemented by immunosuppressive drugs when indicated for patients with severe noninfectious intermediate uveitis, posterior uveitis, or panuveitis [1]. The MUST Trial required standardized, masked evaluation of color fundus photographs of the eyes with uveitis among the patients enrolled in the study across multiple clinical centers to reliably assess the structural complications of intraocular inflammation and the morphological effects of treatment. This report describes the MUST Trial methodology for independent assessment of stereoscopic color photographs by the University of Wisconsin Fundus Photograph Reading Center (RC), provides data on the reproducibility of the evaluation procedures, and reports the baseline color fundus photograph-derived morphologic findings of the trial cohort.
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