自我给药OCT治疗新生血管性年龄相关性黄斑变性疗效的关键试验。报告2：人工智能分析。

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2024-11-26 DOI:10.1016/j.xops.2024.100662

Eric W. Schneider MD , Jeffrey S. Heier MD , Nancy M. Holekamp MD , Miguel A. Busquets MD , Alan L. Wagner MD , S. Krishna Mukkamala MD , Christopher D. Riemann MD , Seong Y. Lee MD , Brian C. Joondeph MD , Steven S. Houston MD , Kester Nahen PhD , Nishant Mohan PhD , Gidi Benyamini MBA

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引用次数: 0

摘要

目的：验证Notal OCT分析仪（NOA）处理家用OCT系统（家用OCT [HOCT]）自给OCT图像的性能，这是一项旨在获得美国食品和药物管理局（fda）重新上市许可的关键研究的一部分。设计：一项前瞻性定量横断面人工智能研究。参与者：该研究招募年龄≥55岁的成年人，诊断为新生血管性年龄相关性黄斑变性（nAMD），≥1只符合条件的眼睛，最佳矫正视力为20/320或更高。方法：参与者在单次就诊期间分别在2台HOCT设备上自行成像4次，在办公室OCT （IO-OCT）设备上自行成像1次。扫描结果由NOA和经认证的阅读中心（RC）的评分员进行分割。主要观察指标：与RC分级器在io - oct图像上的评分相比，NOA在hoct获取图像上的视网膜总低反射（TRO）体积估计在设备内和设备间的可重复性和再现性。此外，与RC分级仪相比，评估NOA在多次b扫描中分割TRO的性能。结果：在2616次尝试中，有2451次（93.7%）的387名参与者成功完成了自我成像。为了可重复性，对于使用HOCT成像的具有bbb10容积单位TRO的眼睛，NOA的方差系数为11.1%，而对于使用RC分级器分割IO-OCT图像的眼睛，NOA的方差系数为16.4%。NOA与分级1、分级2和分级3分割TRO的中位数DICE相似系数1年级与2年级和3年级；2级与3级分别为0.68、0.68、0.61、0.72、0.63、0.70。结论：NOA的表现支持了该系统作为常规临床就诊期间家中TRO监测工具的预期用途，以支持nAMD的管理。财务披露：专有或商业披露可在本文末尾的脚注和披露中找到。

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Pivotal Trial Toward Effectiveness of Self-administered OCT in Neovascular Age-related Macular Degeneration. Report 2—Artificial Intelligence Analytics

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.