Pivotal Trial Validating Usability and Visualization Performance of Home OCT in Neovascular Age-Related Macular Degeneration: Report 1.

Jeffrey S Heier¹, Nancy M Holekamp², Miguel A Busquets³, Michael J Elman⁴, Sidney A Schechet⁴, Byron S Ladd⁵, Kapil G Kapoor⁶, Eric W Schneider⁷, Ella H Leung⁸, Ron P Danis⁹, Kester Nahen¹⁰, Nishant Mohan¹⁰, Gidi Benyamini¹⁰

¹Ophthalmic Consultants of Boston, Boston, Massachusetts.

²Midwest Vision Research Foundation, Chesterfield, Missouri.

³Retina Associates of Kentucky, Lexington, Kentucky.

⁴Elman Retina Group PA, Baltimore, Maryland.

⁵Virginia Eye Institute, Richmond, Virginia.

⁶Wagner Kapoor Institute, Norfolk, Virginia.

⁷Tennessee Retina, PC, Nashville, Tennessee.

⁸Georgia Retina, Atlanta, Georgia.

⁹MERIT CRO Inc., Madison, Wisconsin.

¹⁰Notal Vision Inc., Manassas, Virginia.

PubMed PMC DOI PDF

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 e…

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