NCT04318132

Agreement and Precision Study of the Nidek Mirante

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Nidek Co. LTD. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma
• Retinal Disease
• Corneal Disease

Interventions

Type	Name	Description
DEVICE	Nidek Mirante	The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures.
DEVICE	Optovue RTVue XR Avanti	The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.
DEVICE	Optos P200DTx	The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.

Timeline

• Start date: 2020-01-25
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-03-23
• Last updated: 2023-08-24
• Results posted: 2023-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study