Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363045
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-24
Brief Title:
Comparative Study of the NIDEK TONOREF III With Predicate Devices
Sponsor:
Nidek Co LTD
Organization:
Nidek Co LTD
Study Overview
Official Title:
Comparative Study of the NIDEK TONOREF III With the Haag-Streit Perkins Hand-held Applanation Tonometer for Tonometry Function and NIDEK TONOREF III With the NIDEK CEM-530 for Pachymetry Function
Status:
RECRUITING
Status Verified Date:
2024-06
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 primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device The secondary objective is to demonstrate that the test device is as safe as the predicate devices
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