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前瞻性纵向研究:家用 OCT 每日自我成像用于新生血管性年龄相关性黄斑变性。

Prospective, Longitudinal Study: Daily Self-Imaging with Home OCT for Neovascular Age-Related Macular Degeneration.

机构信息

Ophthalmic Consultants of Boston, Boston, Massachusetts; New England Eye Center, Tufts Medical Center, Boston, Massachusetts.

Pepose Vision Institute, Saint Louis, Missouri.

出版信息

Ophthalmol Retina. 2022 Jul;6(7):575-585. doi: 10.1016/j.oret.2022.02.011. Epub 2022 Feb 28.

Abstract

OBJECTIVE

To validate the performance of the Notal Vision Home OCT (NVHO) system for daily self-imaging at home and characterize the retinal fluid dynamics of patients with neovascular age-related macular degeneration (nAMD).

DESIGN

Prospective observational study.

SUBJECTS

Fifteen participants who had at least 1 eye with nAMD and underwent anti-VEGF treatments.

METHODS

The participants performed daily self-imaging at home using NVHO for 3 months. The scans were uploaded to the cloud, analyzed using the Notal OCT Analyzer (NOA), evaluated by human experts for fluid presence, and compared with in-office OCT scans.

MAIN OUTCOME MEASURES

Weekly self-scan rate, image quality, scan duration, agreement between NOA and human expert grading for fluid presence, agreement between NVHO and in-office OCT scans for fluid presence, central subfield thickness (CST) and retinal fluid volume, and the characteristics of fluid dynamics during the study and in response to treatments.

RESULTS

The mean weekly scan frequency was 5.7 ± 0.9 scans per week, and 93% of the scans were eligible for NOA analyses. The median scan time was 42 seconds. The NOA and human experts agreed on the fluid status in 83% of the scans, and discrepancies were limited to trace amounts of fluid. The NVHO scans analyzed using NOA and the in-office OCT scans graded by human experts agreed on the fluid status in 96% of the cases. The CST and retinal fluid volume measurements using the home OCT and in-office OCT scans demonstrated a Pearson correlation coefficient of r = 0.90 and r = 0.92, respectively. Novel parameters, such as retinal fluid volume and area under the curve (AUC) of retinal fluid volume, demonstrated wide variations in fluid exudation and fluid load over time among the patients. Parameters such as the rate of reduction in fluid volume in the first week after treatment and AUC between treatments captured the speed and duration of the response to anti-VEGF agents.

CONCLUSIONS

Daily home OCT imaging is feasible among patients with nAMD. It demonstrated good agreement with human expert grading for retinal fluid identification and excellent agreement with the in-clinic OCT scans. Home OCT allows for detailed graphical and mathematical analyses of retinal fluid volume trajectories, including novel parameters to inform clinical decision making.

摘要

目的

验证 Notal Vision Home OCT(NVHO)系统在家中进行日常自我成像的性能,并描述新生血管性年龄相关性黄斑变性(nAMD)患者的视网膜液动力学特征。

设计

前瞻性观察研究。

受试者

15 名参与者,他们至少有 1 只眼患有 nAMD 并接受了抗 VEGF 治疗。

方法

参与者使用 NVHO 在家中进行为期 3 个月的日常自我成像。扫描结果上传至云端,使用 Notal OCT Analyzer(NOA)进行分析,由人类专家评估液体存在情况,并与门诊 OCT 扫描进行比较。

主要观察指标

每周自我扫描次数、图像质量、扫描持续时间、NOA 和人类专家对液体存在的分级之间的一致性、NVHO 和门诊 OCT 扫描对液体存在的分级之间的一致性、中央视网膜厚度(CST)和视网膜液体积以及研究期间和治疗反应中液体动力学的特征。

结果

平均每周扫描频率为 5.7±0.9 次/周,93%的扫描结果可用于 NOA 分析。中位扫描时间为 42 秒。NOA 和人类专家对 83%的扫描结果液体状态的判断一致,差异仅限于微量液体。使用 NOA 分析的 NVHO 扫描和由人类专家评估的门诊 OCT 扫描对液体状态的判断在 96%的情况下一致。使用家庭 OCT 和门诊 OCT 扫描测量的 CST 和视网膜液体积之间具有 Pearson 相关系数 r=0.90 和 r=0.92。新型参数(如视网膜液体积和视网膜液体积曲线下面积(AUC))在患者之间显示出液体渗出和液体负荷随时间的广泛变化。参数,如治疗后第 1 周内液体体积减少率和治疗之间的 AUC,捕捉了对抗 VEGF 药物的反应速度和持续时间。

结论

nAMD 患者在家中进行日常 OCT 成像可行。它与人类专家对视网膜液识别的分级具有良好的一致性,与门诊 OCT 扫描具有极好的一致性。家庭 OCT 允许对视网膜液体积轨迹进行详细的图形和数学分析,包括用于指导临床决策的新型参数。

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