Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-30 @ 12:58 AM
Study NCT ID:
NCT01621503
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Sponsor:
Nidek Co. LTD.
Organization:
Study Overview
Official Title:
Prospective Comparative Clinical Study to Investigate the Use of the NON CONTACT TONO/PACHYMETER NT-530P
Status:
COMPLETED
Status Verified Date:
2012-07
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 collect clinical data to support an FDA 510(k) submission for the Nidek Non Contact Tono/ Pachymeter NT-530P. The secondary objective is to evaluate any adverse events found during the clinical study.
Detailed Description:
Following data analysis will be conducted for tonometer and pachymeter readings. One of eyes of one patient becomes an object of the analysis. Regarding the intraocular pressure, higher IOP readings of either right or left eye are used for analysis. Regarding CCT, the readings of either right or left eye are randomly assigned to analysis in the order of registration.
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?: