Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression.
Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression.
复制标题
验证平均偏差变化率作为青光眼进展的临床相关终点。
DOI：
10.1016/j.ophtha.2022.12.025
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发表时间：
2023
期刊：
影响因子：
13.7
通讯作者：
Jammal,AlessandroA
中科院分区：
文献类型：
--
作者：
Medeiros,FelipeA;Jammal,AlessandroA
目的探讨在最初的2年随访期间，标准自动视野测量（SAP）的平均偏差（MD）率是否可以预测在延长随访期间的视野进展事件。设计：纵向、前瞻性、观察性研究。参与者168名青光眼患者的246只眼睛每6个月随访一次，随访时间长达5年。方法要求患者在前2年随访期间至少进行5次可靠的SAP测试。使用两种方法评估进展事件：引导进展分析（GPA；卡尔蔡司医疗公司）和美国食品和药物管理局（FDA）建议的终点。2年后第一次测试显示进展的日期被认为是事件日期。在前2年的随访中计算SAP MD的变化率，并使用联合纵向生存模型来评估基于每个事件分析的初始MD更快丢失的风险。主要结果测量基于SAP MD初始变化率的进展事件的风险。结果56只眼（22.8%）出现GPA进展事件，51只眼（20.7%）出现FDA终点进展事件。在前2年，SAP MD损失率每增加0.1 db /年，GPA进展终点发展的风险增加26% (R2= 76%)，基于fda的终点发展的风险增加32% （R2= 83%）。前2年MD变化率降低30%与5年随访中进展事件的累积概率降低20%相关。结论：在最初的2年随访中计算的青光眼SAP MD变化率可以强烈预测后续随访中的进展事件。我们的研究结果支持使用MD变化斜率作为临床试验进展的合适终点。财务披露在参考文献之后可能会发现专有或商业披露。
PurposeTo investigate whether rates of standard automated perimetry (SAP) mean deviation (MD) over an initial 2-year follow-up period were predictive of events of visual field progression over an extended follow-up.DesignLongitudinal, prospective, observational study.ParticipantsTwo hundred forty-six eyes of 168 patients with glaucoma followed up every 6 months for up to 5 years.MethodsPatients were required to have a minimum of 5 reliable SAP tests during the first 2 years of follow-up. Events of progression were evaluated using 2 methods: Guided Progression Analysis (GPA; Carl Zeiss Meditec, Inc) and a United States Food and Drug Administration (FDA)–suggested end point. The date of the first test showing progression after the first 2 years was considered to be the event date. Rates of change in SAP MD were calculated for the first 2 years of follow-up, and joint longitudinal survival models were used to assess the risk of faster initial MD loss for subsequent progression based on each event analysis.Main Outcome MeasureRisk of having an event of progression based on initial rates of SAP MD change.ResultsFifty-six eye (22.8%) showed an event of progression by the GPA and 51 eyes (20.7%) did so by the FDA end point. Each 0.1-dB/year faster rate of SAP MD loss in the first 2 years was associated with a 26% increase in risk of a GPA progression end point developing (R2= 76%) and 32% risk of an FDA-based end point developing (R2= 83%). A reduction of 30% in the rate of MD change in the first 2 years was associated with a 20% reduction in the cumulative probability of a progression event developing over 5 years of follow-up.ConclusionsRates of SAP MD change for eyes with glaucoma calculated over the initial 2 years of follow-up were strongly predictive of events of progression over subsequent follow-up. Our findings give support for the use of slopes of MD change as suitable end points of progression in clinical trials.Financial Disclosure(s)Proprietary or commercial disclosure may be found after the references.