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Post-Market Study of the Argus® II Retinal Prosthesis System - France

NCT02303288 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2020-06-22

No results posted yet for this study

Summary

This is a post-market study of the Argus II Retinal Prosthesis System. The study is being conducted in France. The objective of the study is to obtain data to further demonstrate the effectiveness and evaluate the safety of Argus II System in patients with retinitis pigmentosa who have a bare light perception or worse in both eyes.

Conditions

Interventions

DEVICE

Argus II Retinal Prosthesis System

The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.

Sponsors & Collaborators

  • Second Sight Medical Products

    lead INDUSTRY

Principal Investigators

  • Pierre-Olivier Barale, MD · CHNO des Quinze-Vingts

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-20
Primary Completion
2018-03-20
Completion
2018-11-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303288 on ClinicalTrials.gov