Meng Yan, Liu Hong-Wei, Sun Peng, Zhou Ping-Ping, Wang Jian-Jie
Department of Ophthalmology, First Affiliated Hospital of Jiamusi University.
Department of Immunology, Jiamusi University, Jiamusi, China.
Medicine (Baltimore). 2019 Mar;98(13):e14516. doi: 10.1097/MD.0000000000014516.
Omega-3 and ranibizumab (O3R) has been reported to treat age-related macular degeneration (ARMD) effectively. However, up to the present, no systematic review specifically addressed the efficacy of O3R for the treatment of ARMD. Therefore, in this study, we will propose to assess the efficacy and safety of O3R for the treatment of ARMD.
We will search PUMBED, EMBASE, CINAHI, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Cochrane Library, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, Wanfang Data, as well as the gray literature from inception up to the present. We will accept randomized controlled trials for assessing the efficacy and safety of O3R for ARMD. The primary outcomes include change in best corrected visual acuity and central retinal thickness. The secondary outcomes consist of changes in subfoveal choroidal thickness, macular atrophy, retinal average sensitivity, contrast sensitivity, glare disability, and quality of life. In addition, incidence and severity of adverse events will also be evaluated. Cochrane Collaboration tool will be used to assess the risk of bias for each included study. In addition, Grading of Recommendations Assessment, Development, and Evaluation tool will be utilized to assess the overall strength of the evidence. Two authors will independently carry out all procedures and any divergences will be solved through discussion with a third author. If it is possible, we will conduct meta-analysis and subgroup analysis concerning different interventions, risk of bias, and outcome measurements.
In this proposed study, we outline details of the aims and methods of efficacy and safety of O3R for the treatment of ARMD.
The findings of this systematic review will summarize current evidence of O3R for the treatment of patients with ARMD.
The results of the present study are expected to be published by peer-reviewed journals. This is a literature-based study. Thus, ethical approval is unnecessary for this study.
PROSPERO CRD42019121177.
据报道,ω-3与雷珠单抗联合使用(O3R)可有效治疗年龄相关性黄斑变性(ARMD)。然而,截至目前,尚无专门针对O3R治疗ARMD疗效的系统评价。因此,在本研究中,我们将评估O3R治疗ARMD的疗效和安全性。
我们将检索PubMed、EMBASE、CINAHL、护理学与健康相关文献累积索引、补充与替代医学数据库、Cochrane图书馆、中国生物医学文献数据库、中国知网、维普资讯、万方数据,以及自创建以来的灰色文献。我们将纳入评估O3R治疗ARMD疗效和安全性的随机对照试验。主要结局包括最佳矫正视力和中心视网膜厚度的变化。次要结局包括黄斑下脉络膜厚度、黄斑萎缩、视网膜平均敏感度、对比敏感度、眩光残疾和生活质量的变化。此外,还将评估不良事件的发生率和严重程度。将使用Cochrane协作工具评估每项纳入研究的偏倚风险。此外,将使用推荐分级评估、制定和评价工具评估证据的总体强度。两位作者将独立进行所有程序,任何分歧将通过与第三位作者讨论解决。如果可能,我们将针对不同干预措施、偏倚风险和结局测量进行荟萃分析和亚组分析。
在本拟进行的研究中,我们概述了O3R治疗ARMD疗效和安全性的目的及方法细节。
本系统评价的结果将总结目前O3R治疗ARMD患者的证据。
本研究结果预计将发表于同行评审期刊。这是一项基于文献的研究。因此,本研究无需伦理批准。
PROSPERO CRD42019121177