Overview
PRIMA bionic vision system including a wireless photovoltaic sub-retinal implant for atrophic dry-AMD in clinical studies in Europe and USA
- · Title of the study: Feasibility Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age Related Macular Degeneration (PRIMA FS and PRIMA-FS-US)
- · ClinicalTrials.gogReference NCT03333954 for the European (Paris) study and NCT03392324 for the USA (Pittsburgh) study
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Reference of the study |
European study |
American study |
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Estimated Enrollment: |
5 implanted subjects Recruitment COMPLETED, study ongoing |
Up to 5 implanted subjects RECRUITING |
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Study Start Date: |
November 2017 |
April 2018 |
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Primary endpoints |
Elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment after implantation |
Elicitation of visual perception by electrical stimulation of the PRIMA implant and complication rates, at 12 months after implantation |
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Secondary end points |
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Assessments at 1 day, 1 week, 6 weeks, 3, 6, 9 , 12, 18, 24 and up to 36 months |
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.
· Title of the study: Compensation for Blindness with the Intelligent Retinal Implant System (IRIS® II) in Patients with Retinal Dystrophy
· Reference: NCT02670980
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Link to the clinical.gov study Reference NCT02670980 |
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Patients Enrollment: |
10 patients, completed |
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Study Start Date: |
January, 2016 |
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Estimated study Completion Date: |
January, 2020 |
