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Title

NR600 System Retinal Prosthesis

Purpose	The NR600 system is a novel retinal prosthetic device which transforms the visual image into an electrical signal and transmits it through an epiretinal array of penetrating electrodes to the functional cells in the inner retina. The purpose of this study is to test the NR600 system for safety and performance in late-stage Retinitis Pigmentosa patients.
Methods	The implantation procedure includes a standard lensectomy and vitrectomy after which the implant is inserted through a limbal incision and positioned on the macula. The implant is anchored by haptics positioned in the ciliary sulcus. Glasses provide the implant with power and communication through an infrared laser beam. Safety of the implantation procedure and long-term presence of the device in the eye was evaluated as well as visual abilities.
Results	Three patients underwent successful implantations. The patients tolerated the procedure well, no signs of discomfort were reported and no major signs of ocular damage. All patients could perceive visual stimuli upon activation of the implant. One patient was evaluated following parameter optimization setting. Her orientation and mobility capabilities improved from none at baseline to 67% with the NR600 system, square localization from 21±10° to 4±3° off center and object localization from none to 76% success.
Conclusion	These early results in human demonstrate a unique potential of regaining functional vision capabilities using a minimally invasive and safe implantation technique. The visual outcome supports the key principle of using penetrating microelectrodes to transmit very low charge to stimulate the inner retinal cells locally.
Conflict of interest	Yes
Details of conflicting interests	Nano-Retina: results presented are from sponsored clinical trial

Authors 1

Last name	STALMANS
Initials	P
Department	Oogheelkunde UZLeuven
City	Leuven