NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2023-03-12

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Retinitis Pigmentosa Retinal Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NR600 device implantation

Retinal surgery and implantation of epi-retinal prosthesis

Group Type EXPERIMENTAL

Retinal surgery with implantation of epi-retinal device

Intervention Type DEVICE

Retinal surgery and implantation of epi-retinal prosthesis

Interventions

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Retinal surgery with implantation of epi-retinal device

Retinal surgery and implantation of epi-retinal prosthesis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No