The Tube Versus Trabeculectomy IRIS® Registry Study: Cohort Selection and Follow-up and Comparisons to the Randomized Controlled Trial.
The Tube Versus Trabeculectomy IRIS® Registry Study: Cohort Selection and Follow-up and Comparisons to the Randomized Controlled Trial.
复制标题
管与小梁切除术 IRIS® 注册研究：队列选择和随访以及与随机对照试验的比较。
DOI：
10.1016/j.ajo.2020.11.014
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发表时间：
2021
影响因子：
4.2
通讯作者：
Gedde,StevenJ
中科院分区：
文献类型：
--
作者：
Vanner,ElizabethA;Sun,CatherineQ;McSoley,MatthewJ;Persad,PatriceJ;Feuer,WilliamJ;Lum,Flora;Kelly,ScottP;Parrish,RichardK;Chang,TaC;Gedde,StevenJ
目的：根据IRIS®注册数据，评估重复随机对照试验（RCT）的可行性，类似于管与小梁切除术（TVT）RCT队列，并比较特征和随访。设计RCT和IRIS注册队列和随访的比较。方法我们确定了IRIS注册眼的队列（2013-2017年），在既往小梁切除术和/或白内障摘除术后接受青光眼引流植入物（管）或小梁切除术;提取基线手术和1年随访访视的临床和人口统计学特征; IRIS登记处队列和这个队列的TVT RCT cohol.ResultsThe IRIS登记处队列包括419眼：183（43.7%）小梁切除术，236（56.3%）管。治疗组之间存在显著差异，包括种族（白色：小梁切除术61.8%，插管44.9%;黑人：小梁切除术20.8%，插管35.6%;P =.003）和完成随访的百分比（小梁切除术88.4%，插管83.8%，P = .004）。TVT IRIS登记队列和TVT RCT队列完成随访访视的百分比也存在显著差异（IRIS登记组85.6%，RCT组96.1%，P <0.001）和1年随访的可能性IRIS登记组81.4%，RCT组89.2%，P = 0.011。结论TVT IRIS登记组队列在基线时有几个显著的治疗组差异，而TVT RCT队列中没有。TVT IRIS登记研究队列的随访劣于TVT RCT。在IRIS登记研究中，无法获得一些用于优化队列眼睛选择的数据。
PurposeTo assess the feasibility of replicating a randomized controlled trial (RCT) with a cohort of eyes, from IRIS® Registry data, analogous to the Tube Versus Trabeculectomy (TVT) RCT cohort and compare characteristics and follow-up.DesignComparison of RCT and IRIS Registry cohorts and follow-up.MethodsWe identified a cohort of IRIS Registry eyes (2013-2017) that received either a glaucoma drainage implant (tube) or trabeculectomy after a previous trabeculectomy and/or cataract extraction; extracted clinical and demographic characteristics for baseline surgery and follow-up visits through 1 year; and compared treatment groups in the IRIS Registry cohort and this cohort to the TVT RCT cohort.ResultsThe IRIS Registry cohort included 419 eyes: 183 (43.7%) trabeculectomy; 236 (56.3%) tube. There were significant differences between treatment groups, including race (White: trabeculectomy 61.8%, tube 44.9%; Black: trabeculectomy 20.8%, tube 35.6%;P =.003) and the percentage of follow-up visits completed (trabeculectomy 88.4%, tube 83.8%,P= .004). There were also significant differences between the TVT IRIS Registry cohort and the TVT RCT cohort in the percentage of follow-up visits completed (IRIS Registry 85.6%, RCT 96.1%,P< .001) and in the probability of having a 1-year follow-up visit (IRIS Registry 81.4%, RCT 89.2%,P= .011).ConclusionThe TVT IRIS Registry cohort had several significant treatment group differences at baseline, whereas there had been none in the TVT RCT cohort. Follow-up in the TVT IRIS Registry cohort was inferior to that of the TVT RCT. Some data needed to refine the selection of eyes for the cohort were not available in the IRIS Registry.
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