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S. B. Reed, S. Gangaputra, D. Friedman, M. M. Altaweel, MUST Trial Study Group; Morphological Assessment for Glaucoma in the Multicenter Uveitis Steroid Treatment Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5809.
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© ARVO (1962-2015); The Authors (2016-present)
1) To describe a system of evaluation for glaucomatous optic nerve change in a clinical trial of treatments for uveitis. 2) To compare reading center evaluation of optic nerve morphology with evaluation performed by clinic investigators.Background: The MUST Trial is a randomized clinical trial comparing the effectiveness of standard systemic therapy versus the fluocinolone acetonide intraocular implant for treatment of severe non-infectious uveitis. The implant previously has been described to have a high incidence of intraocular pressure elevation, with ~ 40% requiring surgical management over a three-year follow-up. One facet of assessment for glaucoma in this trial is evaluation for change in optic nerve morphology.
Stereoscopic photographs from baseline and follow-up visits are graded for morphological changes, including measurement of cup-to-disc (CD) ratio using a procedure adapted from the WESDR Cup Disc Measurement Protocol. In the clinical centers, the cup-to-disc ratio is estimated by biomicroscopic examination.
332 eyes enrolled in the study were graded at baseline. 58 eyes (17%) were ungradable at the reading center because stereo images were missing or media opacity precluded fundus viewing. There was 28% exact agreement between reading center and clinical grades. Agreements within 0.1 and 0.2 CD ratio were 63% and 92%, respectively. Intraclass correlation (ICC) was 0.47. Inter-grader reproducibility for CD ratio grading at the reading center was 63% within 0.1 and 94.6% within 0.2 (ICC = 0.60).
The level of agreement between clinicians and graders was moderate at baseline, whereas inter-grader agreement at the reading center was better. The exact masked measurements of cup-to-disc ratios are more likely to be accurate in identifying meaningful anatomical change in response to elevated intraocular pressure. The reproducibility results argue for longitudinal grading. Comparison of Reading Center and clinician identification of significant increases in CD ratio will be conducted in follow-up. Reading Center longitudinal grading for optic nerve changes is an integral part of glaucoma surveillance in the MUST trial.
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