Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427180
Status:
UNKNOWN
Last Update Posted:
2010-03-03
First Post:
2007-01-25
Brief Title:
IRIS PILOT - Extended Pilot Study With a Retinal Implant System
Sponsor:
Intelligent Medical Implants GmbH
Organization:
Intelligent Medical Implants GmbH
Study Overview
Official Title:
Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SP-80-00-00-00-03-V01 | OTHER | IMI Intelligent Medical Implants GmbH | None |
| SP-80-00-00-00-02-V01 | OTHER | None | None |