自我给药光学相干断层扫描在新生血管性年龄相关性黄斑变性中有效性的关键试验。报告2-人工智能分析
Pivotal Trial Toward Effectiveness of Self-administered OCT in Neovascular Age-related Macular Degeneration. Report 2-Artificial Intelligence Analytics.
作者信息
Schneider Eric W, Heier Jeffrey S, Holekamp Nancy M, Busquets Miguel A, Wagner Alan L, Mukkamala S Krishna, Riemann Christopher D, Lee Seong Y, Joondeph Brian C, Houston Steven S, Nahen Kester, Mohan Nishant, Benyamini Gidi
机构信息
Tennessee Retina, PC, Nashville, Tennessee.
Ophthalmic Consultants of Boston, Boston, Massachusetts.
出版信息
Ophthalmol Sci. 2024 Nov 26;5(2):100662. doi: 10.1016/j.xops.2024.100662. eCollection 2025 Mar-Apr.
PURPOSE
To validate the performance of the Notal OCT Analyzer (NOA) in processing self-administered OCT images from an OCT system designed for home use (home OCT [HOCT]) as part of a pivotal study aimed at achieving de novo United States Food and Drug Admininstration marketing authorization.
DESIGN
A prospective quantitative cross-sectional artificial intelligence study.
PARTICIPANTS
The study enrolled adults aged ≥55 years diagnosed with neovascular age-related macular degeneration (nAMD) in ≥1 eligible eye with a best-corrected visual acuity of 20/320 or better.
METHODS
Participants self-imaged 4 times on each of 2 HOCT devices and once with an in-office OCT (IO-OCT) device during a single visit. Scans were segmented by the NOA and human graders at a certified reading center (RC).
MAIN OUTCOME MEASURES
Intradevice and interdevice repeatability and reproducibility of total retinal hyporeflective (TRO) volume estimation by the NOA on HOCT-acquired images as compared with that of RC graders on IO-OCT-acquired images. Additionally, to assess the performance of the NOA in segmentation of TRO over multiple B-scans as compared with RC graders.
RESULTS
Self-imaging was performed successfully by 387 participants in 2451 of 2616 attempts (93.7%). For repeatability, the coefficient of variance for NOA was 11.1% for eyes with >10 volume units of TRO imaged with HOCT compared with 16.4% for RC graders segmenting IO-OCT images. The median DICE similarity coefficients for segmentation of TRO by NOA vs. Grader 1, Grader 2, and Grader 3; Grader 1 vs. Grader 2 and Grader 3; and Grader 2 vs. Grader 3 were 0.68, 0.68, 0.61, 0.72, 0.63, 0.70, respectively.
CONCLUSIONS
The performance of NOA supports the intended use of the system as a tool to monitor TRO at home between routine clinical visits in support of the management of nAMD.
FINANCIAL DISCLOSURES
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的
作为一项旨在获得美国食品药品监督管理局（FDA）全新上市许可的关键研究的一部分，验证Notal OCT分析仪（NOA）处理来自家用OCT系统（家用OCT [HOCT]）的自我管理OCT图像的性能。
设计
一项前瞻性定量横断面人工智能研究。
参与者
该研究纳入了年龄≥55岁、至少一只符合条件的眼睛被诊断为新生血管性年龄相关性黄斑变性（nAMD）且最佳矫正视力为20/320或更好的成年人。
方法
参与者在单次就诊期间，在两台HOCT设备上各自行4次自我成像，并使用办公室内OCT（IO - OCT）设备进行1次成像。扫描图像由NOA和认证阅读中心（RC）的人工分级人员进行分割。
主要观察指标
与RC分级人员对IO - OCT获取图像的分级相比，NOA对HOCT获取图像的总视网膜低反射（TRO）体积估计的设备内和设备间重复性及再现性。此外，评估与RC分级人员相比，NOA在多个B扫描上对TRO的分割性能。
结果
387名参与者在2616次尝试中的2451次（93.7%）成功完成自我成像。对于重复性，HOCT成像的TRO体积大于10体积单位的眼睛，NOA的变异系数为11.1%，而RC分级人员对IO - OCT图像进行分割的变异系数为16.4%。NOA与分级人员1、分级人员2和分级人员3对TRO分割的中位DICE相似系数；分级人员1与分级人员2和分级人员3；以及分级人员2与分级人员3分别为0.68、0.68、0.61、0.72、0.63、0.70。
结论
NOA的性能支持该系统作为一种工具的预期用途，即在常规临床就诊之间在家中监测TRO，以辅助nAMD的管理。
财务披露
本文末尾的脚注和披露中可能会找到专有或商业披露信息。
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