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    Retinal prosthetic device beneficial for blind patients with retinitis pigmentosa

     

    Visual function

    To evaluate patients’ visual skills, three new computer-based tests were developed during the trial: the Square Localization test, in which subjects had to locate and touch a white square on a black touchscreen; the Direction of Motion test, which required patients to draw the direction in which they perceived a white bar to be moving across the same black screen; and the Grating Visual Acuity test, in which patients gave the perceived orientation of a black and white grating, the spacing of which was varied to assess resolution.

    Most patients showed significantly better visual function (system on versus system off) in Square Localization and Direction of Motion at both 1 and 3 years. Some performance decline over time was noted but was considered to probably be a statistical feature of the late introduction of some of the tests and the better array used in patients who enrolled later in the trial: 1-year data were not available for all tests from the patients who enrolled early, which skewed some of the 3-year data.

    One-third to one-half of patients scored on the Grating Visual Acuity test with the system turned on (no patients scored with it turned off).

    The study’s secondary end-points were related to real-world performance and day-to-day life. Patients were better at finding a simulated (black) door in a (light) room and following a 6-inch-wide white line on a black floor with the system turned on.

    The Functional Low-vision Observer Rated Assessment (FLORA), which incorporates extensive interview and observation to evaluate the device’s impact on patients’ everyday lives, was developed in partnership with the FDA for the purposes of this trial. The Argus II System was related as overwhelmingly positive using FLORA, with no negative ratings from any patient at any time point.

    Next: Safety and reliability

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