Status:
TERMINATED
NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases
Lead Sponsor:
Nano Retina
Collaborating Sponsors:
MedPass International
Conditions:
Retinitis Pigmentosa
Retinal Degeneration
Eligibility:
All Genders
18-80 years
Phase:
NA
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 dise...
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 retina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04295304
Start Date
January 17 2020
End Date
March 12 2023
Last Update
March 15 2023
Active Locations (6)
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1
UZ Ghent
Ghent, Belgium
2
UZ Leuven
Leuven, Belgium
3
Rabin Medical Center
Petah Tikva, Israel
4
Sourasky Medical Center
Tel Aviv, Israel