Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-06 @ 4:14 PM
Study NCT ID:
NCT02447133
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2015-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Sponsor:
Topcon Medical Systems, Inc.
Organization:
Study Overview
Official Title:
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
Status:
COMPLETED
Status Verified Date:
2022-06
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 objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
Detailed Description:
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.
Study Oversight
Has Oversight DMC:
False
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?: