Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515814
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2007-08-13
Brief Title:
Retina Implant Pilot Trial to Evaluate Safety Efficacy in Blind Patients Having Degenerated Photo-receptors
Sponsor:
Retina Implant AG
Organization:
Retina Implant AG
Study Overview
Official Title:
A Prospective Open Pilot Study With Functional Placebo-control to Evaluate the Efficacy and TolerabilitySafety of a Subretinal Implant in Blind Patients in Accordance With ICHGCP Guidelines
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
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:
The outcome of this trial will reveal the possibilities of the retinal implant to improve the situation of patients with hereditary retinal blindness caused by degenerations of the outer retina This pilot study will give important information on safety and efficacy of sub-retinal implants
Detailed Description:
Although the design of the chip with a possible resolution of up to 1500 image points has the potential of providing object recognition the quality of the image transmitted in this first human application cannot be foreseen On the other hand clinical experience teaches us that even bare light recognition improves mobility of patients because of the ability to localize bright light sources such as windows or lamps
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 |
|---|---|---|---|
| Retina Implant Project | None | None | None |