Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software

NCT04486976 | Completed FDA Device

• 1 other identifier: TomeyCASIA2-001
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective comparative, randomized, single center study to gather agreement and precision data in all subjects.

Conditions

Glaucoma; Cataract

Outcome Measures

Primary Outcomes (16)

• Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Thickness of Cornea

  Up to 30 days

• Agreement of Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Angle-Opening Distance Angle-Opening Distance

  Up to 30 days

• Agreement of Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Trabecular-Iris Space Area

  Up to 30 days

• 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

  Corneal thickness

  Up to 30 days

• Precision of the Angle-Opening Distance (mm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Angle-Opening Distance

  Up to 30 days

• Precision of the Trabecular-Iris Space Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Trabecular-Iris Space Area

  Up to 30 days

• Precision of the Anterior Corneal Depth measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Anterior Corneal Depth

  Up to 30 days

• Precision of the Anterior Corneal Width measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Anterior Corneal Width

  Up to 30 days

• Precision of the Pupil Diameter measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Pupil Diameter

  Up to 30 days

• Precision of the Ks (steep meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Ks (steep meridian)

  Up to 30 days

• Precision of the Kf (flat meridian) measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Kf (flat meridian)

  Up to 30 days

• Precision of the Corneal Cylinder measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Corneal Cylinder

  Up to 30 days

• Precision of the Average Keratometry measurement (D) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Average Keratometry

  Up to 30 days

• Precision of the Angle Recess Area measurement (mm²) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Angle Recess Area

  Up to 30 days

• Precision of the Trabecular-Iris Angle measurement (mm) for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT

  Trabecular-Iris Angle

  Up to 30 days

Secondary Outcomes (1)

• Adverse Events

  Up to 30 days

Study Arms (3)

Normal

EXPERIMENTAL

Device: Cornea/Anterior Segment OCT CASIA2; Device: Optovue RTVue XR Avanti

Glaucoma

EXPERIMENTAL

Device: Cornea/Anterior Segment OCT CASIA2; Device: Optovue RTVue XR Avanti

Cataract

EXPERIMENTAL

Device: Cornea/Anterior Segment OCT CASIA2; Device: Optovue RTVue XR Avanti

Interventions

Cornea/Anterior Segment OCT CASIA2 DEVICE

Cornea/Anterior Segment OCT CASIA2 The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal thickness. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.

Cataract; Glaucoma; Normal

Optovue RTVue XR Avanti 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.

Cataract; Glaucoma; Normal

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study;

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging;
• Subjects with any current ocular pathology, as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
• Subjects that present with an active ocular infection in either eye;
• Subjects who have a history of ocular surgery, including laser therapy/surgery;
• Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
• Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
• Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
• Subjects who agree to participate in the study;
• Subjects diagnosed with cataract classified per the LOCS III scale;
• Subjects unable to tolerate ophthalmic imaging;
• Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;
• Subjects that present with an active ocular infection in either eye;
• Subjects who have a history of ocular surgery, including laser therapy/surgery;
• Subjects with a condition or in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;

Sponsors & Collaborators

• Tomey Corporation: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Glaucoma; Cataract

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: June 27, 2020
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)