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Vol. LXIII, No. 14
July 08, 2011

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NEI, FDA Work Together on Clinical Trials
NEI, FDA Work Together on Clinical Trials

NEI director Dr. Paul Sieving (second from l) meets with organizers of the NEI/FDA Use of Functional Vision Endpoints in Visual Prostheses Development symposium. They are (from l) Dr. Frederick Ferris, NEI clinical director; Dr. Malvina Eydelman, Center for Devices and Radiological Health, FDA; Dr. Neil Bressler, Wilmer Eye Institute/Johns Hopkins School of Medicine; and Rhonda Williams of the Association for Research in Vision and Ophthalmology.

The National Eye Institute and the Food and Drug Administration sponsored a recent symposium to examine functional vision outcomes and how they are used in retinal prosthesis clinical trials. NEI supports several projects to develop a retinal prosthesis capable of restoring functional vision to those who are blind from various retinal diseases. A growing body of evidence suggests that functional vision data may provide a better understanding of the practical utility of visual prostheses, beyond the data obtained from standard tests of visual acuity.

Government, academic and industry researchers discussed techniques for measuring performance on real-world tasks such as orientation and mobility and activities of daily living and the challenges of ensuring the reliability and validity of the measurements. The information will be used to refine FDAs draft guidance document for visual prosthesis clinical trials.

The meeting was organized by the Association for Research in Vision and Ophthalmology. It was the fourth in a series of NEI/FDA symposia that explore the issues and challenges of determining clinical trial endpoints and how they are used for the investigation and labeling of medical devices and drugs. NIHRecord Icon

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