Clinical Trial: IRIS PILOT - Extended Pilot Study With a Retinal Implant System

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System

Brief Summary: Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.

Detailed Summary:

The Retinal Implant System consists of three main components, the Retinal Stimulator, which is the component actually implanted into the eye, the visual interface, and the Pocket Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a surgical operation. However, the external components are activated only during the test sessions under the control of the investigator team. In a first step of the investigation a software controlled system on a PC which is connected to the Pocket Processor via Ethernet interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the test session, the blind subject is exposed to a series of these stimulation patterns and he / she has to describe the visual perceptions. Based on his descriptions and in an interactive way, the stimulation signal is subsequently be modulated by changing parameters like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on the PC.

In a second step the visual interface is equipped with a camera which presents realtime images to the subject. Data obtained from the investigation with computer generated patterns in the first step are used in the second step to improve the fitting software for the use in the camera supported system.

Finally the system should enable the subject to recognize simple images supported from the camera.


Sponsor: Intelligent Medical Implants GmbH

Current Primary Outcome: Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross. [ Time Frame: 18 months ]

Original Primary Outcome: Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.

Current Secondary Outcome: Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters [ Time Frame: 18 months ]

Original Secondary Outcome:

  • Standardized perception description : brightness, shape, colour
  • Evaluation of stimulation parameters
  • Point to point discrimination
  • Motion test
  • Long-term adaptation
  • EEP
  • Light perception test
  • Light localisation test
  • Motion direction
  • Grating test


Information By: Intelligent Medical Implants GmbH

Dates:
Date Received: January 25, 2007
Date Started: December 2006
Date Completion: December 2010
Last Updated: March 2, 2010
Last Verified: March 2010