Argus® II Retinal Stimulation System Feasibility Protocol

Status Completed

Clinical Trial Summary

Investigational Phase of the Study: The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa. Post-Approval Phase of the Study: To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

Clinical Trial Description

During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00407602
Study type	Interventional
Source	Second Sight Medical Products
Contact
Status	Completed
Phase	N/A
Start date	September 2006
Completion date	December 31, 2019

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