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    Retinal prosthetic device beneficial for blind patients with retinitis pigmentosa

     

    Safety and reliability

    The longest duration of implant at the time of report was 7.2 years. After 3 years, 29 of the 30 patients retained a functioning device: 1 device was removed at 1.2 years to treat recurrent conjunctival erosion. No devices had failed.

    No eyes were lost and there were no safety concerns. It is worth bearing in mind that the usual concern with ophthalmic adverse events is deterioration of vision, so the risks in patients with such profound blindness are inherently low.

    Rates of adverse events were broadly similar to those seen with glaucoma drainage devices and retinal tacks. Eleven subjects experienced a total of 23 serious adverse events—those requiring treatment—that were related to device or surgery; they included hypotony, conjunctival dehiscence and conjunctival erosion, and there were three cases of presumed endophthalmitis (culture negative) early in the trial. Nineteen of the 30 patients experienced no serious adverse events at all. All serious adverse events were managed with standard ophthalmologic approaches.

    Most adverse events occurred within the early post-operative period, with those few that occurred later tending to be part of a cascade of events that had begun before rather than a new problem.

    Seven early subjects underwent elective revision surgeries to improve the position of the array. Two required surgery 1 week after implantation to reattach the array to the retina.

    New trial

    A new trial is recruiting legally blind patients with severe dry age-related macular degeneration to receive the implant system.

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