Saeed Abera, Guymer Robyn H, Hadoux Xavier, Jannaud Maxime, Dang Darvy, Hodgson Lauren A B, Glover Emily K, Gee Erin E, van Wijngaarden Peter, Wu Zhichao
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia.
Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Australia.
Ophthalmol Sci. 2025 Mar 14;5(4):100763. doi: 10.1016/j.xops.2025.100763. eCollection 2025 Jul-Aug.
To evaluate the effectiveness of different approaches for customizing the selection of a subset of test locations on defect-mapping microperimetry (DMP) for improving the detection of progressive visual function decline in geographic atrophy (GA).
Prospective longitudinal study.
Sixty eyes from 53 participants with GA secondary to age-related macular degeneration.
Participants underwent 3-monthly DMP testing twice at each visit for up to 24 months, where the extent of deep visual sensitivity losses on each test was determined through single presentations of 10-decibel stimuli at 208 locations within the central 8° radius region. Seven outcome measures were derived, which included evaluating the proportion of locations missed (PLM; showing nonresponse to stimuli) on DMP in a subset of test locations based on their proximity to the GA margin, or to locations neighboring repeatably nonresponding points on 2 baseline tests (i.e., missed both tests at baseline). These outcome measures were compared by their coefficient of variation (CoV; reflecting performance for capturing longitudinal changes) and sample size estimates in a 2-arm trial seeking to detect a ≥30% treatment effect. Changes in GA extent and best-corrected visual acuity (BCVA) were evaluated for comparison.
Coefficient of variation and sample size estimates.
Evaluating PLM at points immediately adjacent (<1°) to repeatably nonresponding test locations at baseline (CoV = 47%) was the best performing outcome measure on DMP testing. This measure outperformed BCVA (CoV = 188%; < 0.001) at detecting longitudinal changes and was comparable to evaluating GA extent (CoV = 58%; = 0.097). Sample size requirements in a 24-month trial using this outcome measure on DMP testing were lower by 46% and 94% compared with evaluating GA extent and BCVA, respectively.
Customized evaluation of DMP functional testing results in regions adjacent to repeatably nonresponding locations at baseline improved the detection of longitudinal changes compared with the evaluation of all test locations. These findings show that it is possible to sensitively capture progressive visual function decline with this approach, supporting its use in future GA treatment trials.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
评估在缺陷映射微视野检查（DMP）中定制测试位置子集选择的不同方法，以提高对地理性萎缩（GA）中进行性视觉功能下降的检测效果。
前瞻性纵向研究。
53名年龄相关性黄斑变性继发GA的参与者的60只眼睛。
参与者每3个月进行一次DMP测试，每次就诊时进行两次，共持续24个月，每次测试通过在中央8°半径区域内的208个位置单次呈现10分贝刺激来确定深度视觉敏感度损失的程度。得出了七个结果指标，包括评估基于与GA边缘的接近程度或与两次基线测试中反复无反应点相邻位置的测试位置子集中DMP上遗漏位置的比例（PLM；对刺激无反应）。通过变异系数（CoV；反映捕捉纵向变化的性能）和双臂试验中的样本量估计对这些结果指标进行比较，该试验旨在检测≥30%的治疗效果。评估GA范围和最佳矫正视力（BCVA）的变化以作比较。
变异系数和样本量估计。
在基线时评估紧邻（<1°）反复无反应测试位置的点处的PLM（CoV = 47%）是DMP测试中表现最佳的结果指标。该指标在检测纵向变化方面优于BCVA（CoV = 188%；P < 0.001），并且与评估GA范围相当（CoV = 58%；P = 0.097）。与评估GA范围和BCVA相比，在24个月试验中使用该DMP测试结果指标的样本量要求分别降低了46%和94%。
与评估所有测试位置相比，对基线时反复无反应位置相邻区域的DMP功能测试结果进行定制评估可改善纵向变化的检测。这些发现表明，通过这种方法可以灵敏地捕捉进行性视觉功能下降，支持其在未来GA治疗试验中的应用。
在本文末尾的脚注和披露中可能会发现专有或商业披露信息。
