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Daniel Hammer, Zhuolin Liu, Nikita Kedia, Anant Agrawal, Johnny Tam, Osamah Saeedi; Adaptive optics regulatory science at the FDA. Journal of Vision 2019;19(8):22. doi: https://doi.org/10.1167/19.8.22.
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The Food and Drug Administration (FDA) defines regulatory science as the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of regulated products. New strategic initiatives at the Center for Devices and Radiological Health (CDRH) have focused on helping speed translation of innovative medical devices. Despite demonstration of significant enhancement in the ability to resolve retinal cells, adaptive optics (AO) has yet to gain widespread clinical acceptance. The FDA/CDRH AO regulatory science program is designed to reduce barriers to clinical translation. We developed a multimodal AO (mAO) platform, including scanning laser ophthalmoscopy (SLO) and optical coherence tomography (OCT) channels, to test capabilities and develop new imaging approaches in healthy and diseased eyes. The FDA mAO system resolves cells and structures throughout the retina, including microglia, nerve fiber bundles, axons, and somas of ganglion cells, capillaries, foveal cones, peripheral rods, and retinal pigment epithelium cells. We have started to image inner and outer retinal cells in healthy and diseased eyes to measure differences in density and potential correlations between photoreceptor and ganglion cells deficits. We developed an AO phantom-based model eye to standardize system performance assessment across multiple AOSLO and AOOCT imaging modes. The AO model eye is currently being tested on the FDA and NIH AO systems. The AO model eye is a tool for developers to optimize performance and for regulators to help make clearance decisions across a wide variety of device designs. FDA’s AO program fulfills our mission to advance public health by speeding innovations in the field of optical diagnostic devices.
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