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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Abstract
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.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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