Retinal Degeneration, Retinitis Pigmentosa
Conditions
Brief summary
The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment
Detailed description
The NR600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. The system is consisting of an autonomous epiretinal implant with penetrating electrodes, Glasses and a Clinician Station. The implant is Infrared (IR) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. All study subjects will be implanted with the device in one eye and will be followed for 18-months.
Interventions
DEVICERetinal surgery with implantation of epi-retinal device
Retinal surgery and implantation of epi-retinal prosthesis
Sponsors
MedPass International
Nano Retina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy * Visual acuity in both eyes from light perception to no light perception * Confirmed functional ganglion cells and optic nerve in the implanted eye * History of useful vision * Mentally competent
Exclusion criteria
* Diseases or condition that affect retinal and or optic nerve function * Optic Nerve diseases * Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning * Dry eye * Pre-disposition to eye rubbing * Posterior pole severe staphyloma * Strabismus superior to 10 prismatic diopter * Severe nystagmus * Corneal endothelium density \< 1500 cells/mm2 * Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric * Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects \<50 years of age. * Hyperthyroidism or hypersensitivity to iodine * Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression) * Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study * Conditions likely to limit life to less than 1 year from time of recruitment to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoint | within 9 months post implantation | Occurrence of serious adverse events related to the device and/or to the procedure |
Countries
Belgium, Israel, Italy
Outcome results
None listed