Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519814
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2020-07-22
Brief Title:
Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty SLT
Sponsor:
Carl Zeiss Meditec AG
Organization:
Carl Zeiss Meditec AG
Study Overview
Official Title:
A Prospective Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty SLT
Status:
UNKNOWN
Status Verified Date:
2022-07
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:
An interventional open prospective multi-center pre-market clinical investigation according to 20-23a Medizinproduktegesetz MPG medical devices act in which a total of 40 eyes of 40 consecutive patients at up to five 5 clinical sites will be enrolled treated with the VISULAS green with option CSLT and followed for a three months period
The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT
The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None