Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tomey Corporation
- Enrollment
- 134
- Locations
- 2
- Primary Endpoint
- Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Study Overview
Brief Summary
This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Angle-Opening Distance Angle-Opening Distance
Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Thickness of Cornea
Agreement of OCT image quality for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT and evaluation of visibility of predefined anatomical structures
Time Frame: Up to 30 days
Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Corneal thickness
Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Angle-Opening Distance
Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Ks (steep meridian)
Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Trabecular-Iris Space Area
Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Anterior Corneal Depth
Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Pupil Diameter
Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Average Keratometry
Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Angle Recess Area
Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Kf (flat meridian)
Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Anterior Corneal Width
Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Trabecular-Iris Angle
Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Trabecular-Iris Space Area
Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Time Frame: Up to 30 days
Corneal Cylinder
Secondary Outcomes
- Adverse Events(Up to 30 days)