Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-30 @ 2:59 PM
Study NCT ID:
NCT04318132
Status:
COMPLETED
Last Update Posted:
2023-08-24
First Post:
2020-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Agreement and Precision Study of the Nidek Mirante
Sponsor:
Nidek Co. LTD.
Organization:
Study Overview
Official Title:
Agreement and Precision Study of the Nidek Mirante OCT Compared to the Optovue RTVue XR Avanti OCT and SLO Image Comparison of the Nidek Mirante and the OPTOS P200DTx
Status:
COMPLETED
Status Verified Date:
2023-07
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:
This study is a prospective comparative, randomized, single center study to gather agreement and precision of the Nidek Mirante OCT with SLO and Anterior Segment Imaging capabilities in comparison to the Optovue RTVue XR Avanti OCT and Optos P200DTx in normal subjects, subjects with glaucoma, subjects with retinal disease and subjects with corneal disease.
Detailed Description:
This is a prospective comparative clinical study to be conducted at one clinical site located in the United States. Three Nidek Mirante devices, three Optovue RTVue XR Avanti devices and one OPTOS P200DTx will be used. For agreement and precision analysis of OCT scans and agreement analysis of image quality of OCT ACA scans, each Nidek Mirante device will be paired with one of the Optovue RTVue XR Avanti devices. One device operator will be assigned to each device pair to create three distinct operator/device configurations.
For agreement analysis of SLO image quality, one OPTOS P200DTx will be included in one of three operator/device configurations.
For agreement analysis of SLO image quality, one OPTOS P200DTx will be included in one of three operator/device configurations.
Study Oversight
Has Oversight DMC:
False
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?: