白内障手术中囊样黄斑水肿的预防：网络荟萃分析方案
Cystoid macular edema prophylaxis in cataract surgery: A protocol for network meta-analysis.
作者信息
Nanji Keean, Staibano Phillip, McKechnie Tyler, Zoratti Michael, Chaudhary Varun
机构信息
Department of Surgery, Division of Ophthalmology, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
出版信息
PLoS One. 2024 Dec 17;19(12):e0314467. doi: 10.1371/journal.pone.0314467. eCollection 2024.
OBJECTIVE
Cataracts are the leading cause of global preventable and treatable blindness. Cystoid macular edema (CME) is among the most common complications following cataract surgery. The development of CME impacts patients' quality of life and has economic implications for patients and healthcare systems. The purpose of this review is to synthesize the evidence from randomized controlled trials evaluating patients receiving prophylactic treatment with nonsteroidal anti-inflammatory drugs or corticosteroid medications to determine the comparative effectiveness of each specific regimen on retinal thickness, visual acuity, the development of CME, patient quality of life, intraocular pressure and adverse events following uncomplicated, age-related cataract surgery performed by phacoemulsification.
METHODS
A systematic review and random effects Bayesian network meta-analysis (NMA) will be performed and will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) extension statement for NMA. A comprehensive electronic search will be performed of the MEDLINE, EMBASE and CENTRAL databases, as well as of the ClinicalTrials.gov and World Health Organization International Clinical Trials Registries. Data will be collected and synthesized for seven pre-specified outcomes at 6 weeks and 3 months following surgery: i) change in central retinal thickness measured by optical coherence tomography (OCT), ii) best-recorded visual acuity iii) the rate of CME measured by OCT, and fluorescein angiography (FA) iv) the rate of patients experiencing clinically significant macular edema defined as the presence of CME and pre-specified thresholds for decreased visual acuity, v) patient quality of life, vi) intraocular pressure and vii) the number of patients experiencing one or more pre-specified adverse events. The certainty of evidence for each outcome will be assessed using GRADE NMA guidelines.
DISCUSSION
The results of this NMA will provide a comprehensive evaluation of the evidence for this critical question with significant clinical equipoise.
TRIAL REGISTRATION
Systematic Review Registration: PROSPERO Registration Number: CRD42024531150.
目的
白内障是全球可预防和可治疗失明的主要原因。黄斑囊样水肿（CME）是白内障手术后最常见的并发症之一。CME的发生会影响患者的生活质量，并给患者和医疗系统带来经济影响。本综述的目的是综合来自随机对照试验的证据，这些试验评估了接受非甾体抗炎药或皮质类固醇药物预防性治疗的患者，以确定每种特定治疗方案对视网膜厚度、视力、CME的发生、患者生活质量、眼压以及单纯性年龄相关性白内障超声乳化手术后不良事件的比较效果。
方法
将进行系统评价和随机效应贝叶斯网络荟萃分析（NMA），并按照系统评价和荟萃分析的首选报告项目（PRISMA）扩展声明报告NMA。将对MEDLINE、EMBASE和CENTRAL数据库以及ClinicalTrials.gov和世界卫生组织国际临床试验注册库进行全面的电子检索。将收集并综合手术后6周和3个月时七个预先指定结局的数据：i）光学相干断层扫描（OCT）测量的中心视网膜厚度变化，ii）最佳记录视力，iii）OCT和荧光素血管造影（FA）测量的CME发生率，iv）发生具有临床意义黄斑水肿的患者比例，定义为存在CME且视力下降达到预先指定阈值，v）患者生活质量，vi）眼压，以及vii）发生一种或多种预先指定不良事件的患者数量。将使用GRADE NMA指南评估每个结局的证据确定性。
讨论
本NMA的结果将为这个具有重大临床 equipoise的关键问题的证据提供全面评估。
试验注册
系统评价注册：PROSPERO注册号：CRD42024531150 。
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