Overview


PRIMA wireless sub-retinal photovoltaic bionic vision system study


PRIMA was initially designed for Advanced Atrophic Dry AMD, (Age Related Macular Degeneration). The first in human feasibility study is ongoing and currently recruiting patients.


The objective of the study is to assess elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates. Currently the benefit for the patient is not yet known. The study is an open-label, non-randomized, clinical trial.


Link to the clinical.gov study

Reference NCT03333954

FS PRIMA

Estimated Enrollment:

Up to 5

Study Start Date:

November 2017

Estimated Study Completion Date:

April  2022

IRIS®II Epi-retinal bionic vision system study



IRIS II was designed for retinal dystrophies such as retinitis pigmentosa. Enrollment of this clinical trial has been closed. The study is ongoing but not recruiting patients. The IRIS® II clinical trial, started in January 2016, is a multi-centric, open label, non-randomized prospective European study to assess effectiveness of the IRIS® II Bionic Vision System as treatment intended to compensate for blindness.



Link to the clinical.gov study

Reference NCT02670980

IRIS®II

Patients Enrollment:

10 patients, completed

Study Start Date:

January, 2016

Estimated study Completion Date:

January, 2020