This workshop facilitated discussion among clinicians, researchers, industry, and regulators about the challenging issues posed by the rapid innovations in the OCT device area, and identified many questions that remain unanswered. Both the American Glaucoma Society and the FDA hope that further work will be conducted in this area to advance the missions of both organizationsdto promote excellence in the care of patients with glaucoma and protect and promote public health. With the assistance of the speakers, panelists, and attendees of the workshop, clinical and regulatory issues surrounding diagnostic imaging devices for glaucoma and approaches to evaluate the accuracy, agreement, and precision of measurements were elucidated. In addition, the workshop advanced the regulatory science that forms the basis for shaping FDA recommendations for OCT to facilitate efficient delivery of innovative and effective imaging technologies to the US market. By discussing the benefits, limitations, and future directions of these imaging technologies and their reference databases, we hope to enhance their proper use in clinical practice as well as stimulate further advances in their development and evaluation.
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