Clinical Trial: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (Title in France: Compensation of Vision With the Intelligent Reti

Brief Summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)

Detailed Summary:
Sponsor: Pixium Vision SA

Current Primary Outcome: Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 18 month after implantation ]

All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analysed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Probable benefit [ Time Frame: Up to 18 months after implantation ]

A series of vision test including grating visual acuity, light localization and contrast sensitivity is performed before and after implantation of the device.


Original Secondary Outcome: Same as current

Information By: Pixium Vision SA

Dates:
Date Received: May 15, 2013
Date Started: April 2013
Date Completion: November 2019
Last Updated: January 23, 2017
Last Verified: January 2017