IRIS PILOT - Extended Pilot Study With a Retinal Implant System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00427180|
Recruitment Status : Unknown
Verified March 2010 by Intelligent Medical Implants GmbH.
Recruitment status was: Active, not recruiting
First Posted : January 26, 2007
Last Update Posted : March 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa Cone-Rod Dystrophy Choroideremia||Device: Retinal Implant System (IRIS)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||December 2010|
- Device: Retinal Implant System (IRIS)
AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retinaOther Name: IRIS
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427180
|Principal Investigator:||Gisbert Richard, Prof.||Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf|