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Improved sensitivity of microperimetric outcomes for clinical studies in age-related macular degeneration
Scientific Reports ( IF 4.6 ) Pub Date : 2021-02-26 , DOI: 10.1038/s41598-021-83716-w
Yaniv Barkana 1, 2 , Susanne G Pondorfer 3 , Steffen Schmitz-Valckenberg 4 , Hermann Russ 1 , Robert P Finger 3
Affiliation  

To investigate sensitive outcome measures based exclusively on abnormal points in microperimetry testing of eyes with intermediate age-related macular degeneration (iAMD). 25 eyes of 25 subjects with iAMD had undergone 2 successive tests of mesopic microperimetry with the Macular Integrity Assessment Microperimeter (MAIA), using a custom grid of 33 points spanning the central 14 degrees of the macula. Each point was defined as abnormal if its threshold sensitivity was lower than 1.65 standard deviations (SD) (5%) or 2 SD (2.5%) than the expected threshold in healthy eyes according to the MAIA internal database. Among the 25 eyes there were 11.8 ± 9 and 8.4 ± 8.2 abnormal points at < 5% and < 2.5%, with mean deviation of thresholds from normal − 4.9 ± 1.2 dB and − 5.8 ± 1.5 dB, respectively. These deviations were greater, and their SD smaller, compared with the complete microperimetry grid, − 2.3 ± 2.0 dB. The 95% limits of agreement for average threshold between the 2 successive tests were smaller when only abnormal points were included. Analyzing only abnormal grid points yields an outcome parameter with a greater deviation from normal, a more homogenous dataset, and better test–retest variability, compared with analysis of all grid points. This parameter may thus be more sensitive to change, while moderately limiting the number of potential recruits. The proposed outcome measures should be further investigated as potential endpoints in clinical trials in iAMD.



中文翻译:

提高显微测量结果对年龄相关性黄斑变性临床研究的敏感性

旨在调查完全基于中度年龄相关性黄斑变性 (iAMD) 眼微视野检测异常点的敏感结果测量。25 名患有 iAMD 的受试者的 25 只眼睛使用黄斑完整性评估微周长 (MAIA) 进行了 2 次连续的中视微周测量测试,使用跨越黄斑中央 14 度的 33 个点的自定义网格。根据 MA​​IA 内部数据库,如果每个点的阈值灵敏度低于健康眼预期阈值的 1.65 个标准差 (SD) (5%) 或 2 个 SD (2.5%),则将每个点定义为异常。在 25 只眼中,分别有 11.8 ± 9 和 8.4 ± 8.2 个异常点在 < 5% 和 < 2.5%,阈值与正常的平均偏差分别为 - 4.9 ± 1.2 dB 和 - 5.8 ± 1.5 dB。这些偏差更大,它们的 SD 更小,与完整的微视野网格相比,- 2.3 ± 2.0 dB。当仅包括异常点时,2 次连续测试之间平均阈值的 95% 一致性限制较小。与分析所有网格点相比,仅分析异常网格点会产生与正常偏差更大的结果参数、更同质的数据集和更好的重测变异性。因此,该参数可能对变化更敏感,同时适度限制潜在新兵的数量。作为 iAMD 临床试验的潜在终点,应进一步研究拟议的结果指标。与分析所有网格点相比,仅分析异常网格点会产生与正常偏差更大的结果参数、更同质的数据集和更好的重测变异性。因此,该参数可能对变化更敏感,同时适度限制潜在新兵的数量。作为 iAMD 临床试验的潜在终点,应进一步研究拟议的结果指标。与分析所有网格点相比,仅分析异常网格点会产生与正常偏差更大的结果参数、更同质的数据集和更好的重测变异性。因此,该参数可能对变化更敏感,同时适度限制潜在新兵的数量。作为 iAMD 临床试验的潜在终点,应进一步研究拟议的结果指标。

更新日期:2021-02-26
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