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

NCT ID: NCT04486976

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-27
• Study Completion Date: 2021-03-05

Brief Summary

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

Conditions

Glaucoma; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Normal

Group Type: EXPERIMENTAL

Cornea/Anterior Segment OCT CASIA2

Intervention Type: 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

Intervention Type: 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.

Glaucoma

Group Type: EXPERIMENTAL

Cornea/Anterior Segment OCT CASIA2

Intervention Type: 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

Intervention Type: 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

Group Type: EXPERIMENTAL

Cornea/Anterior Segment OCT CASIA2

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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;

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;

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

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.

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

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tomey Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

TomeyCASIA2-001

Identifier Type: -

Identifier Source: org_study_id