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Hahn, P., Schneider, E.W., Tabandeh, H., Wong, R.W., Emerson, G.G.

期刊名称:JAMA Ophthalmology



摘要:重要性:近年来,使用激光玻璃溶解术治疗有症状的飞蚊症有所增加,但前瞻性研究尚不清楚,并发症发病情况了解甚少。目的:旨在分析激光玻璃体溶解术后自愿报告给美国视网膜协会专家研究与治疗安全(ASRS ReST)委员会(一个独立工作组,负责监测与器械相关和药物相关的安全事件)的并发症。设计,设置和参与研究对象:自2016919日至2017316日,对所有激光玻璃体溶解术并发症(由美国全科医生自愿向ASRS ReST委员会报告)进行回顾性评估。主要预后指标:通过类型分析报告给ASRS ReST委员会的激光玻璃体溶解术后并发症,以了解潜在并发症。结果:研究期间,7名美国玻璃体视网膜专科医师报道了激光玻璃体解溶解术后15例患者共发生了16次并发症。并发症包括导致青光眼升高的眼内压;白内障,包括需要白内障手术的后囊膜缺损;视网膜撕裂,视网膜脱离,视网膜出血;盲点;飞蚊症数量增加。结论和意义:本报告介绍了6个月内向ASRS ReST委员会报告的一系列并发症。并发症发生率无法确定,因为总体病例的分母未知。此外,这些发现无法确定这些并发症与激光玻璃体溶解术之间是否存在因果关系。前瞻性研究有助于更好地了解此手术的疗效和伴随并发症的发生频率。在此之前,医生应该意识到潜在并发症的概况,以便在知情同意过程中正确告知患者。 ASRS REST委员会将继续监测与器械有关和与药物有关的不良事件,并鼓励所有医生进行主动监测和报告。

Importance:Use of laser vitreolysis for symptomatic floaters has increased in recent years, but prospective studies are not available and the complication profile is poorly understood.Objective:To analyze cases of complications following laser vitreolysis as voluntarily reported to the American Society of Retina Specialists Research and Safety in Therapeutics (ASRS ReST) Committee, an independent task force formed to monitor device-related and drug-related safety events.Design, Setting, and Participants:A retrospective assessment was performed of all cases of complications following laser vitreolysis that were voluntarily reported by practitioners throughout the United States to the ASRS ReST Committee from the first report on September 19, 2016, through March 16, 2017, the date of data analysis and manuscript writing.Main Outcomes and Measures:Complications reported to the ASRS ReST Committee following laser vitreolysis were analyzed by type to gain an understanding of the spectrum of potential complications.Results:A total of 16 complications following laser vitreolysis were reported in 15 patients by 7 US vitreoretinal specialists during the study period. Complications included elevated intraocular pressure leading to glaucoma; cataracts, including posterior capsule defects requiring cataract surgery; retinal tear; retinal detachment; retinal hemorrhages; scotomas; and an increased number of floaters.Conclusions and Relevance:This report presents a spectrum of complications reported to the ASRS ReST Committee across 6 months. The rate of complications cannot be determined because the denominator of total cases is unknown. Also, these findings cannot determine whether there is a causal association between these complications and laser vitreolysis. Prospective studies are warranted to better understand the efficacy of this procedure and the frequency of attendant complications. Until then, practitioners should be aware of the profile of potential complications to properly inform patients during the consent process. The ASRS ReST Committee will continue to monitor device-related and drug-related adverse events and encourages active surveillance and reporting by all physicians.


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