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Argus II Retinal Prosthesis System - Better Vision RP Study

NCT03418116 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-25

No results posted yet for this study

Summary

The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.

Conditions

Interventions

DEVICE

Argus II Retinal Prosthesis

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

  • Peter Walter, Prof Dr med · RWTH Aachen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-11-30
Completion
2021-11-30
FDA Device
Yes

Countries

  • Germany

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 NCT03418116 on ClinicalTrials.gov