Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06186388
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2023-12-15
Brief Title:
Glaucoma Screening
Sponsor:
Cape Fear Eye Institute
Organization:
Cape Fear Eye Institute
Study Overview
Official Title:
TEMPO iMOvifa Glaucoma Screening
Status:
COMPLETED
Status Verified Date:
2024-08
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 primary objective of this study is to evaluate the diagnostic accuracy of the TEMPO iMOvifa visual field perimeter screening test by measuring the sensitivity in a population of eyes with glaucoma and the specificity in a population of normal eyes and to measure repeatability of the screening test
The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma
The secondary objective of this study is to gather and analyze ancillary data to confirm the diagnosis or absence of glaucoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None