Abstract
PURPOSE. To examine the association between visual function response (VFR) and inflammation reduction in active noninfectious uveitis of the posterior segment (NIU-PS). METHODS. Phase 3 SAKURA Study 1 randomized 347 subjects in a double-masked fashion to receive injections of intravitreal sirolimus 44 mu g (n = 117);440 mu g (n = 114);or 880 mu g (n = 116) every other month. Vitreous haze (VH) response, a measure of inflammation reduction, was defined as a VH score of 0 or 0.5+ at month 5 based on the modified Standardized Uveitis Nomenclature Scale. Visual function was assessed with best-corrected visual acuity (BCVA) and the National Eye Institute (NEI) Visual Function Questionnaire-25 (VFQ-25). In this post-hoc analysis, principal component analysis was used to reduce the information in the multidimensional visual function outcome to a restricted number of independently relevant VFR measures. Minimal clinically important differences (MCID) for the VFQ-25-derived components were based on the standard error of measurements. Overall VFR was defined as either a BCVA improvement of >= 2 lines, or an improvement exceeding the MCID in the VFQ-25 based visual function measures. RESULTS. The VFQ-25 composite score (VFQCS) and mental health subscale score (VFQMHS) were retained as relevant VFRs, with MCIDs of 4.3 and 11.7 points, respectively. A vitreous haze response was significantly associated with each VFR measure: VFQCS (odds ratio [ OR] = 2.23;P = 0.0004);VFQMHS (OR = 2.84;P < 0.0001);BCVA (OR = 2.60;P = 0.0009), and overall VFR (OR = 2.65;P < 0.0001). CONCLUSIONS. Inflammation reduction to a VH score of 0 or 0.5+ was significantly associated with improved visual function. Achieving a VH response of 0 or 0.5+ is a patient-relevant outcome.
Dokumententyp: | Zeitschriftenartikel |
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Fakultät: | Medizin |
Themengebiete: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit |
ISSN: | 0146-0404 |
Sprache: | Englisch |
Dokumenten ID: | 52823 |
Datum der Veröffentlichung auf Open Access LMU: | 14. Jun. 2018, 09:51 |
Letzte Änderungen: | 23. Dez. 2020, 13:25 |