Clinical Trial: Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy

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

Official Title: Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy

Brief Summary: This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. 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 analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.

Detailed Summary:
Sponsor: Pixium Vision SA

Current Primary Outcome: Number of participants with treatment-related adverse events according to ISO14155 [ Time Frame: up to 36 month ]

All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual acuity [ Time Frame: up to 36 month ]
    Measure probable benefit with square wave grating test
  • Square localization [ Time Frame: up to 36 month ]
    Measure probable by measuring the error in localizing a white square on black background.
  • Functional Vision [ Time Frame: up to 36 month ]
    Measure probable benefit e.g. by Functional Picture Assessment. The number of errors subjects make in detecting objects or persons on standardized pictures is measures. Other test may be developed during the study.


Original Secondary Outcome: Same as current

Information By: Pixium Vision SA

Dates:
Date Received: January 4, 2016
Date Started: January 2016
Date Completion: April 2022
Last Updated: January 23, 2017
Last Verified: January 2017