title: Is acuity enough? Other considerations in clinical investigations of visual prostheses.
abstract: Visual impairing eye diseases are the major frontier facing ophthalmic research today in light of our rapidly aging population. The visual skills necessary for improving the quality of daily function and life are inextricably linked to these impairing diseases. Both research and reimbursement programs are emphasizing outcome-based results. Is improvement in visual acuity alone enough to improve the function and quality of life of visually impaired persons? This perspective summarizes the types of effectiveness endpoints for clinical investigations of visual prostheses that go beyond visual acuity. The clinical investigation of visual prostheses should include visual function, functional vision and quality of life measures. Specifically, they encompass contrast sensitivity, orientation and mobility, activities of daily living and quality of life assessments. The perspective focuses on the design of clinical trials for visual prostheses and the methods of determining effectiveness above and beyond visual acuity that will yield outcomes that are measured by improved function in the visual world and quality of life. The visually impaired population is the primary consideration in this presentation with particular emphases on retinitis pigmentosa and age-related macular degeneration. Clinical trials for visual prostheses cannot be isolated from the need for medical rehabilitation in order to obtain measurements of effectiveness that produce outcomes/evidence-based success. This approach will facilitate improvement in daily function and quality of life of patients with diseases that cause chronic vision impairment.
authors.affiliation: US Food and Drug Administration, Rockville, MD 20852, USA.
authors.forename: Bernard P
authors.initials: BP
authors.lastname: Lepri
mesh_terms: D001185:Artificial Intelligence; D001698:Biomedical Engineering / Q000295:instrumentation*; D001766:Blindness / Q000534:rehabilitation*; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000639:trends; D004567:Electrodes, Implanted; D006801:Humans; D019736:Prostheses and Implants; D011474:Prosthesis Design / Q000379:methods; D014792:Visual Acuity / Q000502:physiology*