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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486976
• Other study ID #: TomeyCASIA2-001
• Status: Completed
• Phase: N/A
• Start date: June 27, 2020
• Est. completion date: March 5, 2021

Study information

• Verified date: August 2021
• Source: Tomey Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 5, 2021
• Est. primary completion date: March 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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:

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

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

5. 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:

1. 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;

2. 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.

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tomey Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Adverse Events	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.	Up to 30 days