Special Commentary: Food and Drug Administration and American Glaucoma Society Co-sponsored Workshop: The Validity, Reliability, and Usability of Glaucoma Imaging Devices

Abstract

of optic nerve structure and function is the basis for the diagnosis and management of glaucoma. 2,3 Advances in computerized imaging devices to assess the anatomy of the optic nerve complex (retinal ganglion cell layer, retinal nerve fiber layer [RNFL], optic disc, and parapapillary region) are improving our understanding of glaucomatous neurodegeneration and may ultimately be shown to result in improved outcomes for patients. Over the past decade, there has been a significant increase in the number of premarket submissions for imaging devices received by the US Food and Drug Administration (FDA), which has been accompanied by a dramatic rise in the use of ocular imaging devices in the management of glaucoma. 4 As with any diagnostic device, appropriate use can enhance patient care, and inaccurate classification or misinterpretation of results can lead to a delay in diagnosis or unnecessary treatment and associated patient anxiety, increased costs, and risks associated with unnecessary treatments. In light of these concerns about the appropriate use of these devices in ophthalmic care, the FDA and the American Glaucoma Society sought expert opinions on ways to facilitate the correct use of these devices and to promote innovation in this device area. OnOctober5,2012,theFDAandtheAmericanGlaucoma Society co-sponsored a workshop at the FDA’s Silver Spring campus to discuss imaging devices used in the diagnosis and management of glaucoma with an emphasis on optical coherence tomography (OCT) devices. 5 The specific goals of the workshop were to provide a platform for physicians, researchers, and FDA colleagues interested in the field of imaging devices for glaucoma to discuss the construction, reliability, and usability (what to convey to the user) of normative databases; to enhance the proper use of these databases and imaging technologies in clinical practice; to elucidate approaches to evaluate the accuracy, agreement, and precision of measurements; and to advance and clarify the regulatory science in the field of imaging devices. The workshop agenda with links to the speaker’s slides, a transcript of the workshop proceedings, and the Webcast of the workshop are available online at the FDA website (available at: http://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ucm318305.htm# agenda).