Bertelmann Thomas, Feltgen Nicolas, Scheffler Martin, Hufenbach Ulrich, Wiedon Annette, Wilhelm Helmut, Ziemssen Focke
Department of Ophthalmology, University Medical Center Goettingen, Robert-Koch-Straße 40, 37075, Goettingen, Germany.
Novartis Pharma GmbH, Nuremberg, Germany.
Health Qual Life Outcomes. 2016 Sep 20;14(1):132. doi: 10.1186/s12955-016-0536-1.
Vision-related quality of life (vrQoL) is advancing more and more into the focus of interest in ophthalmological clinical research. However, to date only little information is available about vrQoL from large non-interventional studies in terms of "real-world evidence". The purpose of this investigation was to describe baseline VFQ-25 visual function scores, to evaluate whether they differ from previous phase III clinical trials, to determine which contributing factors (e.g. indication, age, gender) affect VFQ-25 scores and to identify its impact on driving.
The non-interventional OCEAN study (Observation of treatment patterns with LuCEntis and real life ophthalmic monitoring, including optional OCT in Approved iNdications) is the largest ophthalmic study conducted in Germany, to evaluate the real world situation of patients treated with ranibizumab (NCT02194803). The NEI-VFQ-25 questionnaire was conducted at baseline, months 4, 12 and 24. Descriptive statistics was used to analyse the baseline data. ANOVA was performed to evaluate the impact of various contributing factors on composite and selected subscale scores.
Overall, 4844 (84.1 %) of all 5760 OCEAN patients completed the VFQ-25 questionnaire at baseline. Thereof, 3414 treatment-naïve patients were further analysed. Overall, the VFQ subscore general health was most affected by the ocular disease, followed by general vision. No major differences were detected in comparison to corresponding VFQ-25 scores of previous phase III clinical trials, except in DME patients, or with respect to possible contributing factors. A tendency towards a more decreased VFQ-25 composite score was observed for nAMD, for elderly patients ≥75 years of age, for female patients, for patients with low baseline visual acuity (VA; <50 letters) and for those with statutory health insurance. Indication, age, gender, baseline VA (all p <0.01) and the interaction of age and indication, as well as baseline VA and indication (p <0.01 each) had a significant impact on composite, general vision and distance vision scores (ANOVA). About 10 % of patients gave up driving due to eyesight issues.
The knowledge of a patient's subjective disease burden is crucial to understanding anxieties and mental anguish. Additionally, the understanding of the impact of various contributing factors on the VFQ-25 scores and the extent to which they can be influenced help to optimize patient care. It demonstrates the need for medical and mental support by all medical staff, to encourage patients' compliance with a comprehensive anti-VEGF therapy, to increase BCVA and, consecutively, VFQ-25 scores.
NCT02194803.
与视觉相关的生活质量（vrQoL）在眼科临床研究中越来越受到关注。然而，迄今为止，关于“真实世界证据”方面的大型非干预性研究中，有关vrQoL的信息仍然很少。本研究的目的是描述基线VFQ-25视觉功能评分，评估其与先前III期临床试验是否存在差异，确定哪些影响因素（如适应症、年龄、性别）会影响VFQ-25评分，并确定其对驾驶的影响。
非干预性OCEAN研究（观察Lucentis的治疗模式及现实生活中的眼科监测，包括批准适应症中的可选OCT）是德国开展的最大规模眼科研究，旨在评估接受雷珠单抗治疗患者的真实世界情况（NCT02194803）。在基线、第4、12和24个月时进行NEI-VFQ-25问卷调查。采用描述性统计分析基线数据。进行方差分析以评估各种影响因素对综合及选定子量表评分的影响。
总体而言，5760名OCEAN患者中有4844名（84.1%）在基线时完成了VFQ-25问卷调查。其中，对3414名初治患者进行了进一步分析。总体而言，VFQ子量表中总体健康受眼部疾病影响最大，其次是总体视力。与先前III期临床试验的相应VFQ-25评分相比，除糖尿病性黄斑水肿（DME）患者或在可能的影响因素方面外，未发现重大差异。对于新生血管性年龄相关性黄斑变性（nAMD）患者、75岁及以上老年患者、女性患者、基线视力较低（VA；<50个字母）的患者以及参加法定医疗保险的患者，观察到VFQ-25综合评分有下降趋势。适应症、年龄、性别、基线视力（均p<0.01）以及年龄与适应症的相互作用，以及基线视力与适应症（均p<0.01）对综合、总体视力和远视力评分有显著影响（方差分析）。约10%的患者因视力问题放弃驾驶。
了解患者主观疾病负担对于理解焦虑和精神痛苦至关重要。此外了解各种影响因素对VFQ-25评分的影响以及这些因素的可影响程度有助于优化患者护理。这表明所有医务人员都需要提供医疗和心理支持，以鼓励患者坚持全面抗VEGF治疗，提高最佳矫正视力（BCVA），进而提高VFQ-25评分。
NCT02194803
