Heier Jeffrey S, Holekamp Nancy M, Busquets Miguel A, Elman Michael J, Schechet Sidney A, Ladd Byron S, Kapoor Kapil G, Schneider Eric W, Leung Ella H, Danis Ron P, Nahen Kester, Mohan Nishant, Benyamini Gidi
Ophthalmic Consultants of Boston, Boston, Massachusetts.
Midwest Vision Research Foundation, Chesterfield, Missouri.
Ophthalmol Sci. 2025 Mar 21;5(5):100772. doi: 10.1016/j.xops.2025.100772. eCollection 2025 Sep-Oct.
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.
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.
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.
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.
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.
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.
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.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
在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中，验证家用光学相干断层扫描系统（HOCT）指标测试的可用性和可视化性能。
一项为期5周的前瞻性纵向居家可视化多中心研究，在第1周和第5周进行预先计划好的门诊就诊，并根据需要进行临时就诊。
该研究招募了年龄≥55岁的成年人，这些人至少有一只符合条件的眼睛被诊断为接受抗血管内皮生长因子（VEGF）治疗的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。
参与者在家中自行安装HOCT并进行每日成像，为期5周，在第1周和第5周进行2至3次穿插的门诊就诊，并根据临时阅读中心（RC）触发进行就诊，包括使用对照门诊光学相干断层扫描（IO - OCT）。质量信号指数可接受的扫描由RC以盲法独立分级。
在家中自我成像的能力，HOCT和IO - OCT上总低反射空间（TRO）可视化的阳性和阴性百分比一致性（NPA）。
在家中，自我成像成功率为96.1%（95%置信区间[CI]：92.2% - 98.4%）。180名参与者对主要和次要眼睛分别进行了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）。阳性百分比一致性为86.6%（95% CI：80.4% - 92.8%），NPA为86.1%（95% CI：80.4% - 9
