The potential of the second sight system bionic eye implant for partial sight restoration.

INTRODUCTION: Second Sight System bionic eye implant, a commercially available visual prosthesis developed by Second Sight Medical Products, has been implanted in over 125 patients with outer retinal dystrophies such as retinitis pigmentosa. The system has gained regulatory approval in both the USA and Europe, and aims to restore vision by electrical stimulation of the nerve cells of the inner retina. AREAS COVERED: In this review, we present the safety profile of this implant from the international clinical trial and discuss the nature and levels of improvement in visual function achieved by patients implanted with the system. Expert commentary: Future developments for the system will be explored following the discussion of the current usefulness of the device, its limitation as and the areas in which further development is necessary.

The Argus(®) II Retinal Prosthesis System.

The Argus(®) II Retinal Prosthesis System (Second Sight Medical Products) is the first prosthetic vision device to obtain regulatory approval in both Europe and the USA. As such it has entered the commercial market as a treatment for patients with profound vision loss from end-stage outer retinal disease, predominantly retinitis pigmentosa. To date, over 100 devices have been implanted worldwide, representing the largest group of patients currently treated with visual prostheses. The system works by direct stimulation of the relatively preserved inner retina via epiretinal microelectrodes, thereby replacing the function of the degenerated photoreceptors. Visual information from a glasses-mounted video camera is converted to a pixelated image by an external processor, before being transmitted to the microelectrode array at the macula. Elicited retinal responses are then relayed via the normal optic nerve to the cortex for interpretation. We reviewed the animal and human studies that led to the development of the Argus(®) II device. A sufficiently robust safety profile was demonstrated in the phase I/II clinical trial of 30 patients. Improvement of function in terms of orientation and mobility, target localisation, shape and object recognition, and reading of letters and short unrehearsed words have also been shown. There remains a wide variability in the functional outcomes amongst the patients and the factors contributing to these performance differences are still unclear. Future developments in terms of both software and hardware aimed at improving visual function have been proposed. Further experience in clinical outcomes is being acquired due to increasing implantation.

The use of Argus® II retinal prosthesis by blind subjects to achieve localisation and prehension of objects in 3-dimensional space.

BACKGROUND: The Argus® II retinal prosthesis system has entered mainstream treatment for patients blind from Retinitis Pigmentosa (RP). We set out to evaluate the use of this system by blind subjects to achieve object localisation and prehension in 3-dimensional space. METHODS: This is a single-centre, prospective, internally-controlled case series involving 5 blind RP subjects who received the Argus® II implant. The subjects were instructed to visually locate, reach and grasp (i.e. prehension) a small white cuboid object placed at random locations on a black worktop. A flashing LED beacon was attached to the reaching index finger (as a finger marker) to assess the effect of enhanced finger visualisation on performance. Tasks were performed with the prosthesis switched "on" or "off" and with the finger marker switched "on" or "off". Forty-eight trials were performed per subject. Trajectory of each subject's hand movement during the task was recorded by a 3D motion-capture unit (Qualysis®, see supplementary video) and analysed using a MATLAB script. RESULT: Percentage of successful prehension±standard deviation was: 71.3 ± 27.1 % with prosthesis on and finger marker on; 77.5 ± 24.5 % with prosthesis on and finger marker off; 0.0 ± 0.0 % with prosthesis off and finger marker on, and 0.00 ± 0.00 % with prosthesis off and finger marker off. The finger marker did not have a significant effect on performance (P = 0.546 and 1, Wilcoxon Signed Rank test, with prosthesis on and off respectively). With prosthesis off, none of the subjects were able to visually locate the target object and no initiation of prehension was attempted. With prosthesis on, prehension was initiated on 82.5 % (range 59-100 %) of the trials with 89.0 % (range 66.7-100 %) achieving successful prehension. CONCLUSION: Argus® II subjects were able to achieve object localisation and prehension better with their prosthesis switched on than off.