作者: Thomas Bertelmann , Nicolas Feltgen , Martin Scheffler , Ulrich Hufenbach , Annette Wiedon
DOI: 10.1186/S12955-016-0536-1
关键词: Visual acuity 、 Quality of life 、 Descriptive statistics 、 Physical therapy 、 Baseline (configuration management) 、 Disease burden 、 Optometry 、 Ranibizumab 、 Affect (psychology) 、 Clinical research 、 Medicine
摘要: Vision-related quality of life (vrQoL) is advancing more and into the focus interest in ophthalmological clinical research. However, to date only little information available about vrQoL from large non-interventional studies terms "real-world evidence". The purpose this investigation was describe baseline VFQ-25 visual function scores, evaluate whether they differ previous phase III trials, determine which contributing factors (e.g. indication, age, gender) affect scores identify its impact on driving. OCEAN study (Observation treatment patterns with LuCEntis real ophthalmic monitoring, including optional OCT Approved iNdications) largest conducted Germany, world situation patients treated ranibizumab (NCT02194803). NEI-VFQ-25 questionnaire at baseline, months 4, 12 24. Descriptive statistics used analyse data. ANOVA performed various composite selected subscale scores. Overall, 4844 (84.1 %) all 5760 completed baseline. Thereof, 3414 treatment-naive were further analysed. VFQ subscore general health most affected by ocular disease, followed vision. No major differences detected comparison corresponding except DME patients, or respect possible factors. A tendency towards a decreased score observed for nAMD, elderly ≥75 years female low acuity (VA; <50 letters) those statutory insurance. Indication, gender, VA (all p <0.01) interaction age as well indication (p <0.01 each) had significant composite, vision distance (ANOVA). About 10 % gave up driving due eyesight issues. knowledge patient’s subjective disease burden crucial understanding anxieties mental anguish. Additionally, extent can be influenced help optimize patient care. It demonstrates need medical support staff, encourage patients’ compliance comprehensive anti-VEGF therapy, increase BCVA and, consecutively, NCT02194803