IRIS PILOT - Extended Pilot Study With a Retinal Implant System

Not Applicable

• Conditions: Choroideremia; Retinitis Pigmentosa; Cone-Rod Dystrophy

• Registration Number: NCT00427180
• Lead Sponsor: Intelligent Medical Implants GmbH

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 Description

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-25
• Study First Posted: 2007-01-26
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-03
• Primary Completion: 2010-11
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	18 months

Secondary Outcome Measures

Name	Time	Method
Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters	18 months