基于点亚组的视野终点在青光眼临床试验中可能有用：使用 Humphrey 视野分析仪和 Compass 视野计进行的研究。

Visual Field Endpoints Based on Subgroups of Points May Be Useful in Glaucoma Clinical Trials: A Study With the Humphrey Field Analyzer and Compass Perimeter.

机构信息

Sam Rothberg Glaucoma Center, Goldschleger Eye Institute, Sheba Medical Center, affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Galimedix Therapeutics, Kensington, MD.

出版信息

J Glaucoma. 2021 Aug 1;30(8):661-665. doi: 10.1097/IJG.0000000000001856.

DOI:10.1097/IJG.0000000000001856

PMID:33899809

Abstract

PRECIS

Visual field (VF) endpoints based on average deviation of specific subsets of points rather than all points may offer a more homogeneous data set without necessarily worsening test-retest variability and so may be useful in clinical trials.

PURPOSE

The purpose of this study was to characterize the outcome measures encompassing particular subsets of VF points and compare them as obtained with Humphrey [Humphrey visual field analyser (HVF)] and Compass perimeters.

METHODS

Thirty patients with imaging-based glaucomatous neuropathy performed a pair of 24-2 tests with each of 2 perimeters. Nonweighted mean deviation (MD) was calculated for the whole field and separate vertical hemifields, and again after censoring of points with low sensitivity (MDc) and subsequently including only "abnormal" points with a total deviation probability of <5% (MDc5%) or <2% (MDc2%). Test-retest variability was assessed using Bland-Altman 95% limits of agreement (95%LoA).

RESULTS

For the whole field, using HVF, MD was -7.5±6.9 dB, MDc -3.6±2.8 dB, MDc5% -6.4±1.7 dB, and MDc2% -7.3±1.5 dB. With Compass the MD was -7.5±6.6, MDc -2.9±1.7 dB, MDc5% -6.3±1.5, and MDC2% -7.9±1.6. The respective 95%LoA were 5.5, 5.3, 4.6, and 5.6 with HVF, and 4.8, 3.7, 7.1, and 7.1 with Compass. The respective number of eligible points were 52, 42±12, 20±11, and 15±9 with HVF, and 52, 41.2±12.6, 10±7, and 7±5 with Compass. With both machines, SD and 95%LoA increased in hemifields compared with the total field, but this increase was mitigated after censoring.

CONCLUSION

Restricting analysis to particular subsets of points of interest in the VF after censoring points with low sensitivity, as compared with using the familiar total field MD, can provide outcome measures with a broader range of MD, a markedly reduced SD and therefore more homogeneous data set, without necessarily worsening test-retest variability.

摘要

基于特定点子集的平均偏差而不是所有点的视场 (VF) 终点可能提供更同质的数据组，而不一定会增加测试-重测变异性，因此在临床试验中可能有用。

目的

本研究的目的是描述包含 VF 点特定子集的结果测量，并比较使用 Humphrey [Humphrey 视野分析仪 (HVF)] 和 Compass 周边获得的结果。

方法

30 名患有基于影像学的神经青光眼患者使用两种周边设备进行了一对 24-2 测试。计算了全视野和单独垂直半视野的非加权平均偏差 (MD)，并在对低敏度点进行屏蔽后再次计算 (MDc)，随后仅包括总偏差概率 <5% (MDc5%) 或 <2% (MDc2%) 的“异常”点。使用 Bland-Altman 95%一致性界限 (95%LoA) 评估测试-重测变异性。

结果

对于整个视野，使用 HVF，MD 为 -7.5±6.9dB，MDc 为 -3.6±2.8dB，MDc5% 为 -6.4±1.7dB，MDc2% 为 -7.3±1.5dB。使用 Compass，MD 为 -7.5±6.6，MDc 为 -2.9±1.7dB，MDc5% 为 -6.3±1.5，MDC2% 为 -7.9±1.6。HVF 的相应 95%LoA 为 5.5、5.3、4.6 和 5.6，Compass 的相应 95%LoA 为 4.8、3.7、7.1 和 7.1。HVF 的合格点数分别为 52、42±12、20±11 和 15±9，Compass 的合格点数分别为 52、41.2±12.6、10±7 和 7±5。与全视野相比，使用两种仪器后，半视野的 SD 和 95%LoA 增加，但在屏蔽低敏度点后，这种增加得到缓解。