Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software
- Conditions
- CataractGlaucoma
- Interventions
- Device: Cornea/Anterior Segment OCT CASIA2Device: Optovue RTVue XR Avanti
- Registration Number
- NCT04486976
- Lead Sponsor
- Tomey Corporation
- Brief Summary
This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Normal Cornea/Anterior Segment OCT CASIA2 - Glaucoma Optovue RTVue XR Avanti - Normal Optovue RTVue XR Avanti - Glaucoma Cornea/Anterior Segment OCT CASIA2 - Cataract Optovue RTVue XR Avanti - Cataract Cornea/Anterior Segment OCT CASIA2 -
- Primary Outcome Measures
Name Time Method Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT 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 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 Up to 30 days Precision of the Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT 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 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 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 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 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 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 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 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 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 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 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 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 Up to 30 days Corneal Cylinder
- Secondary Outcome Measures
Name Time Method Adverse Events Up to 30 days An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational device but not necessarily related to the investigational device.
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States