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

Sponsor
Tomey Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04486976
Collaborator
(none)
134
Enrollment
1
Location
3
Arms
8.2
Actual Duration (Months)
16.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Cornea/Anterior Segment OCT CASIA2
  • Device: Optovue RTVue XR Avanti
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
134 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software
Actual Study Start Date :
Jun 27, 2020
Actual Primary Completion Date :
Mar 5, 2021
Actual Study Completion Date :
Mar 5, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Normal

Device: Cornea/Anterior Segment OCT CASIA2
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.

Device: Optovue RTVue XR Avanti
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.

Experimental: Glaucoma

Device: Cornea/Anterior Segment OCT CASIA2
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.

Device: Optovue RTVue XR Avanti
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.

Experimental: Cataract

Device: Cornea/Anterior Segment OCT CASIA2
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.

Device: Optovue RTVue XR Avanti
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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]

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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)

  13. 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

  14. 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

  15. 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

  16. 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

Secondary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria - Normal Group:
  1. 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;

  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

  3. Subjects who agree to participate in the study;

Exclusion Criteria - Normal Group:
  1. Subjects unable to tolerate ophthalmic imaging;

  2. 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;

  3. Subjects that present with an active ocular infection in either eye;

  4. Subjects who have a history of ocular surgery, including laser therapy/surgery;

  5. 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.

Inclusion Criteria - Cataract Group:
  1. 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;

  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

  3. Subjects who agree to participate in the study;

  4. Subjects diagnosed with cataract classified per the LOCS III scale;

Exclusion Criteria - Cataract Group:
  1. Subjects unable to tolerate ophthalmic imaging;

  2. Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;

  3. Subjects that present with an active ocular infection in either eye;

  4. Subjects who have a history of ocular surgery, including laser therapy/surgery;

  5. 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

Inclusion Criteria - Glaucoma Group:
  1. 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;

  2. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;

  3. Subjects who agree to participate in the study;

  4. Subjects with glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

  5. Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;

  6. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

  7. History of Visual field defects within the previous six (6) months from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:

  8. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;

  9. Glaucoma hemi-field test "outside normal limits."

Exclusion Criteria - Glaucoma Group:
  1. Subjects unable to tolerate ophthalmic imaging;

  2. Subjects with corneal or conjunctival abnormalities that may affect adequate assessment of the anterior chamber in either eye;

  3. Subjects that present with an active ocular infection in either eye;

  4. No reliable Humphrey Field Analyzer (HFA) visual field (24-2 Sita Standard, white on white) result within 6 months of the study visit, defined as fixation losses > 33% or false positives > 33%, or false negatives > 33% in the study eye;

  5. 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Andover Eye AssociatesAndoverMassachusettsUnited States01810

Sponsors and Collaborators

  • Tomey Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tomey Corporation
ClinicalTrials.gov Identifier:
NCT04486976
Other Study ID Numbers:
  • TomeyCASIA2-001
First Posted:
Jul 27, 2020
Last Update Posted:
Aug 30, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2021