关键试验验证家庭OCT在新生血管性年龄相关性黄斑变性中的可用性和可视化性能：报告1

IF 3.2 Q1 OPHTHALMOLOGY

Ophthalmology science Pub Date : 2025-03-21 DOI:10.1016/j.xops.2025.100772

Jeffrey S. Heier MD , Nancy M. Holekamp MD , Miguel A. Busquets MD , Michael J. Elman MD , Sidney A. Schechet MD , Byron S. Ladd MD , Kapil G. Kapoor MD , Eric W. Schneider MD , Ella H. Leung MD , Ron P. Danis MD , Kester Nahen PhD , Nishant Mohan PhD , Gidi Benyamini MBA

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引用次数: 0

摘要

目的验证家用OCT系统（HOCT）指标测试的可用性和可视化性能，以获得美国食品药品监督管理局（fda）的新上市许可。设计一项前瞻性、5周纵向、在家可视化的多中心研究，在第1周和第5周进行预先计划的办公室访问，并根据需要进行临时访问。该研究招募了年龄≥55岁的成年人，诊断为新生血管性年龄相关性黄斑变性（nAMD），至少有一只符合条件的眼睛接受抗vegf治疗，最佳矫正视力为20/320或更高。方法：参与者在家中自行安装HOCT并每天进行成像，为期5周，在第1周和第5周进行2或3次穿插的办公室访问，并在阅读中心（RC）触发的临时访问中进行比较，包括办公室OCT （IO-OCT）。具有可接受质量信号指数的扫描由RC以屏蔽方式独立分级。主要结果测量：家庭自我形象的可测性，HOCT和IO-OCT上总低反射空间（TRO）可视化的正负百分比一致性（NPA）。结果在家中，自显像成功率为96.1%（95%可信区间[CI]: 92.2% ~ 98.4%）。180名参与者分别对主眼睛和副眼睛进行了5426次和4012次自我成像，平均（标准差）制造商信号质量指数分别为4.40（1.26）和4.58（1.28）。正面同意率为86.6% (95% CI: 80.4%-92.8%)， NPA为86.1% (95% CI: 80.4%-91.8%)，几乎所有的分歧都很小。结论目标人群成功自行安装并在家中自行成像，图像质量可与IO-OCT媲美。可视化研究的结果支持将该系统作为nAMD管理期间常规临床访问期间家中TRO监测工具的预期用途。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 Validating Usability and Visualization Performance of Home OCT in Neovascular Age-Related Macular Degeneration: Report 1

Purpose

To validate the usability and visualization performance of the index test of the home OCT system (HOCT) during a pivotal study toward de novo US Food and Drug Administration marketing authorization.

Design

A prospective, 5-week longitudinal, at-home visualization multicenter study with preplanned office visits at week 1 and week 5 and as-needed interim visits.

Participants

The study enrolled adults aged ≥55 years diagnosed with neovascular age-related macular degeneration (nAMD) on anti-VEGF therapy in at least 1 eligible eye and best-corrected visual acuity of 20/320 or better.

Methods

Participants self-installed and imaged daily with the HOCT at home for 5 weeks with 2 or 3 interspersed office visits at 1 and 5 weeks with interim reading center (RC)-triggered visits including a comparator in-office OCT (IO-OCT). Scans with an acceptable quality signal index were independently graded by the RC in a masked manner.

Main Outcome Measures

Ability to self-image at home, positive and negative percent agreement (NPA) in visualization of total hyporeflective spaces (TRO) on HOCT and on IO-OCT.

Results

At home, self-imaging success rate was 96.1% (95% confidence interval [CI]: 92.2%–98.4%). One hundred eighty participants self-imaged the primary and secondary eyes 5426 and 4012 times with a mean (standard deviation) manufacturer signal quality index of 4.40 (1.26) and 4.58 (1.28), respectively. Positive percent agreement was 86.6% (95% CI: 80.4%–92.8%) and NPA was 86.1% (95% CI: 80.4%–91.8%), with nearly all disagreements being minimal.

Conclusions

The target population successfully self-installed and self-imaged at home with image quality comparable to IO-OCT. The findings of the visualization study support the intended use of the system as a tool to monitor TRO at home between routine clinical visits during the management of nAMD.