Validation of Rates of Mean Deviation Change as Clinically Relevant End Points for Glaucoma Progression

Ophthalmology Volume 130, Number 5, May 2023

中文摘要

本研究使用兩種方法評估病情進展： Guided Progression Analysis (GPA) 和美國食品和藥物管理局(FDA)建議的終點(endpoint)。標準自動視野檢測(SAP)仍然是監測青光眼功能變化的首選方法，青光眼是全球導致不可逆失明的主要原因。視野評估在臨床護理中的角色除了用於評估新的治療方法以減緩或停止青光眼進展外。本研究中，患者必須在基線訪視時被診斷為原發性開角型青光眼。眼睛被納入的條件是他們在基線訪視時有連續（2次）的視野檢測結果異常。研究結果顯示，SAP平均偏差(MD)變化的斜率可以作為臨床試驗中新的青光眼治療方法的合適終點。總體而言，這些分析顯示，用Ordinary Least Squares得到的斜率也能預測未來的進展事件，並進一步支持我們的結論。

English Abstract

This study assessed disease progression using two methods: Guided Progression Analysis (GPA) and an endpoint suggested by the United States Food and Drug Administration (FDA). Standard Automated Perimetry (SAP) remains the preferred method for monitoring functional changes in glaucoma, a leading cause of irreversible blindness globally. Visual field assessment, besides its role in clinical care, can serve as an endpoint for evaluating new treatments aimed at slowing or halting glaucoma progression. In this study, patients were required to have a diagnosis of primary open-angle glaucoma at the baseline visit. The conditions for inclusion of eyes were that they had consecutive (2) abnormal visual field test results at the baseline visit. The study results show that slopes of change in SAP Mean Deviation (MD) could serve as suitable endpoints in clinical trials investigating potential new therapies in glaucoma. Overall, these analyses demonstrate that slopes obtained with Ordinary Least Squares (OLS) were also predictive of future progression events, providing further support to our conclusions.