Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT00776451
Status:
COMPLETED
Last Update Posted:
2009-06-03
First Post:
2008-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usability of the PreView PHP for Home Use in Intermediate AMD Patients
Sponsor:
Notal Vision Ltd.
Organization:
Study Overview
Official Title:
Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients
Status:
COMPLETED
Status Verified Date:
2009-06
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:
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.
Detailed Description:
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.
Study Oversight
Has Oversight DMC:
True
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?: