平均偏差变化率作为青光眼进展的临床相关终点的验证。
Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression.
机构信息
Vision, Imaging and Performance Laboratory, Duke Eye Center, Duke University, Durham, North Carolina; Department of Electrical and Computer Engineering, Pratt School of Engineering, Duke University, Durham, North Carolina; Department of Biostatistics and Bioinformatics, Duke University School Medicine, Durham, North Carolina.
Vision, Imaging and Performance Laboratory, Duke Eye Center, Duke University, Durham, North Carolina.
出版信息
Ophthalmology. 2023 May;130(5):469-477. doi: 10.1016/j.ophtha.2022.12.025. Epub 2022 Dec 24.
PURPOSE
To 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.
DESIGN
Longitudinal, prospective, observational study.
PARTICIPANTS
Two hundred forty-six eyes of 168 patients with glaucoma followed up every 6 months for up to 5 years.
METHODS
Patients 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 MEASURE
Risk of having an event of progression based on initial rates of SAP MD change.
RESULTS
Fifty-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 (R = 76%) and 32% risk of an FDA-based end point developing (R = 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.
CONCLUSIONS
Rates 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.
目的
研究初始 2 年随访期间标准自动视野计（SAP）平均偏差（MD）的速率是否可预测延长随访期间视野进展事件。
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，每 6 个月随访一次，最长随访 5 年。
方法
患者在前 2 年的随访中需要至少有 5 次可靠的 SAP 测试。使用两种方法评估进展事件：引导性进展分析（GPA；卡尔蔡司 Meditec，Inc）和美国食品和药物管理局（FDA）建议的终点。将首次 2 年后首次出现进展的首次测试日期视为事件日期。计算前 2 年随访期间 SAP MD 的变化率，并使用联合纵向生存模型，根据每种事件分析，评估初始 MD 较快丧失与随后进展的更快初始 MD 丧失风险。
主要观察指标
基于 SAP MD 变化的初始速率，发生进展事件的风险。
结果
GPA 显示 56 只眼（22.8%）和 FDA 终点显示 51 只眼（20.7%）发生进展事件。在前 2 年，SAP MD 损失率每增加 0.1dB/年，GPA 进展终点发展的风险增加 26%（R=76%），FDA 终点发展的风险增加 32%（R=83%）。在前 2 年，MD 变化率降低 30%，5 年随访期间进展事件发生的累积概率降低 20%。
结论
青光眼患者在最初 2 年随访期间 SAP MD 变化率与随后随访期间的进展事件高度相关。我们的发现支持使用 MD 变化率作为临床试验中进展的合适终点。
利益冲突
参考文献后可能有专有或商业披露。
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