Skip to main content
OpenTrials
Completed

NCT Number: NCT04486976

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Normal Group:

  • 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;

Exclusion criteria

- Normal Group:

  • 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.

Inclusion criteria

- Cataract Group:

  • 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;

Exclusion criteria

- Cataract Group:

  • 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

Inclusion criteria

- Glaucoma Group:

  • 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 with glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
  • Diffuse thinning, focal narrowing, or notching of the neuroretinal rim, especially at the inferior or superior poles with or without disc hemorrhage;
  • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
  • 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:
  • 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;
  • Glaucoma hemi-field test "outside normal limits."

Exclusion criteria

- Glaucoma Group:

  • 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;
  • 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;
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  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

    Time frame: Up to 30 days

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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)

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tomey Corporation

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2020
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.