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

Eric W Schneider¹, Jeffrey S Heier², Nancy M Holekamp³, Miguel A Busquets⁴, Alan L Wagner⁵, S Krishna Mukkamala⁶, Christopher D Riemann⁷, Seong Y Lee⁸, Brian C Joondeph⁹, Steven S Houston¹⁰, Kester Nahen¹¹, Nishant Mohan¹¹, Gidi Benyamini¹¹

¹Tennessee Retina, PC, Nashville, Tennessee.

²Ophthalmic Consultants of Boston, Boston, Massachusetts.

³Midwest Vision Research Foundation, Chesterfield, Missouri.

⁴Retina Associates of Kentucky, Lexington, Kentucky.

⁵Wagner Kapoor Institute, Norfolk, Virginia.

⁶Georgia Retina, Marietta, Georgia.

⁷Cincinnati Eye Institute, Cincinnati, Ohio.

⁸Strategic Clinical Research Group, LLC, Willow Park, Texas.

⁹Colorado Retina Associates, PC, Lakewood, Colorado.

¹⁰Florida Retina Institute, PA, Orlando, Florida.

¹¹Notal Vision Inc., Manassas, Virginia.

PubMed PMC DOI PDF

Abstract

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 stud…

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