TY - JOUR
T1 - Special commentary
T2 - Food and drug administration and American glaucoma society co-sponsored workshop: The validity, reliability, and usability of glaucoma imaging devices
AU - Meier, Kristen L.
AU - Greenfield, David S.
AU - Hilmantel, Gene
AU - Kahook, Malik Y.
AU - Lin, Carol
AU - Rorer, Eva M.
AU - Singh, Kuldev
AU - Tarver, Michelle E.
AU - Weinreb, Robert N.
AU - Eydelman, Malvina B.
AU - Liebmann, Jeffrey M.
N1 - Publisher Copyright:
© 2014 American Academy of Ophthalmology.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84908470958&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84908470958&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2014.05.024
DO - 10.1016/j.ophtha.2014.05.024
M3 - Article
C2 - 25085628
AN - SCOPUS:84908470958
SN - 0161-6420
VL - 121
SP - 2116
EP - 2123
JO - Ophthalmology
JF - Ophthalmology
IS - 11
ER -