Agreement and Precision Study of the Nidek Mirante

Agreement and Precision Study of the Nidek Mirante OCT Compared to the Optovue RTVue XR Avanti OCT and SLO Image Comparison of the Nidek Mirante and the OPTOS P200DTx

This study is a prospective comparative, randomized, single center study to gather agreement and precision of the Nidek Mirante OCT with SLO and Anterior Segment Imaging capabilities in comparison to the Optovue RTVue XR Avanti OCT and Optos P200DTx in normal subjects, subjects with glaucoma, subjects with retinal disease and subjects with corneal disease.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Retinal Disease; Corneal Disease
• Intervention / Treatment: Device: Nidek Mirante; Device: Optovue RTVue XR Avanti; Device: Optos P200DTx

Detailed Description

This is a prospective comparative clinical study to be conducted at one clinical site located in the United States. Three Nidek Mirante devices, three Optovue RTVue XR Avanti devices and one OPTOS P200DTx will be used. For agreement and precision analysis of OCT scans and agreement analysis of image quality of OCT ACA scans, each Nidek Mirante device will be paired with one of the Optovue RTVue XR Avanti devices. One device operator will be assigned to each device pair to create three distinct operator/device configurations.

For agreement analysis of SLO image quality, one OPTOS P200DTx will be included in one of three operator/device configurations.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01840
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria - Normal Group:

1. Male or female subjects from 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 normal eye examinations (without pathology other than cataract) in both eyes on the date of the study visit as observed with a +90 Diopter Fundus Lens;
5. Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in both eyes on the date the study visit.

Exclusion Criteria - Normal Group:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye;
3. Subjects with any current ocular pathology other than cataract in either eye, as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
4. Subjects with (or history of) leukemia, dementia or multiple sclerosis;
5. Subject has a condition or will be 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 from 22 years of age or older who have full legal capacity to volunteer on the date the informed consent was 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 who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or RNFL structural abnormalities observed via fundus exam during the study visit:

   1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
   2. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue;
5. Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit;

6. History of a reliable Humphrey Field Analyzer (HFA) visual field (24-2 SITA Standard, white on white) measured on the day of study visit 1, or within the previous six (6) months from study visit 1 with reliable results, defined as fixation losses < 20%, or false positives < 33%, or false negatives < 33% in the glaucoma study eye(s) that is consistent with glaucomatous optic nerve damage in glaucoma study eye(s) based on at least one of the following 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; or
   2. Glaucoma hemi-field test "outside normal limits."

Exclusion Criteria - Glaucoma Group:

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the glaucoma study eye(s);
3. Subjects with retinal disease in the glaucoma study eye(s), as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
4. Subjects with (or history of) leukemia, dementia or multiple sclerosis;
5. Subject has a condition or will be 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 - Retinal Disease 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 a current BSCVA of 20/400 or better in the retinal disease study eye(s) at the study visit;
5. Subjects diagnosed with retinal pathology including but not limited to: Non Exudative Macular Degeneration (dry AMD), Diabetic Macular Edema, Macular Hole, Epiretinal Membrane, Cystoid Macular Edema, or other retinal disease in the study eye(s) as confirmed within the past six (6) months, who exhibit structural lesions in the study eye.

Exclusion Criteria - Retinal Disease Group

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
3. Subjects with glaucoma in the retinal disease study eye(s), as determined by self-report and confirmed by the investigator assessment and/or confirmed by the investigator assessment at the study visit;
4. Subjects with (or history of) leukemia, dementia or multiple sclerosis;
5. Subject has a condition or will be 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 - Corneal 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 a current BSCVA of 20/400 or better in the study eye(s) at the study visit;
5. Subjects with corneal pathologies including but not limited to: Post status LASIK surgery, Keratoconus, or other corneal dystrophies or degenerations in the study eye(s) as confirmed within the past six (6) months.

Exclusion Criteria - Corneal Group

1. Subjects unable to tolerate ophthalmic imaging;
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
3. Subjects with (or history of) leukemia, dementia or multiple sclerosis;
4. Subject has a condition or will be 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIDEK Mirante Comparison - Normal; Subjects without any current ocular pathology other than cataract in either eye	Device: Nidek Mirante; The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures.; 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.; Device: Optos P200DTx; The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
Experimental: NIDEK Mirante Comparison - Retina; Subjects diagnosed with retinal pathology	Device: Nidek Mirante; The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures.; 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.; Device: Optos P200DTx; The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
Experimental: NIDEK Mirante Comparison - Glaucoma; Subjects who have been diagnosed with glaucoma	Device: Nidek Mirante; The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures.; 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.; Device: Optos P200DTx; The P200DTx scanning laser ophthalmoscope (SLO) is indicated for use as a widefield and retinal fluorescence and autofluorescence imaging ophthalmoscope to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina.
Experimental: NIDEK Mirante Comparison - Corneal disease; Subjects with corneal pathologies	Device: Nidek Mirante; The Nidek Mirante Optical Coherence Tomography (OCT) including scanning laser ophthalmoscope (SLO) function is an non-contact system for imaging the fundus and for axial cross sectional imaging of anterior and posterior ocular structures.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Agreement of the measured Macular thickness (μm) between the test device and the predicate device for the OCT function of NIDEK Mirante.	1 day
Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Agreement of the measured Retinal nerve fiber layer thickness around Optic nerve head between the test device and the predicate device for the OCT function of NIDEK Mirante.	1 day
Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Agreement of the measured Corneal thickness between the test device and the predicate device for the OCT function of NIDEK Mirante.	1 day
Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx	Agreement of the SLO Image quality between the test device and the predicate device for the SLO function of NIDEK Mirante. The image quality of is graded Clinical Utility and Overall Utility for each image patterns (SLO Color Fundus, SLO B-FAF and SLO G-FAF) on a Likert scale. The grading used the 0-3 point scale, and higher scores mean a better image quality.	1 day
Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT	Agreement of the ACA Image quality between the test device and the predicate device for the OCT function of NIDEK Mirante. The image quality of is graded Clinical Utility and Overall Utility on a Likert scale. The grading used the 0-3 point scale, and higher scores mean a better image quality.	1 day
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Precision (repeatability) of the measured Full retinal thickness at Macula for the OCT function of the NIDEK TONOREF III.	1 day
Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Precision (repeatability) of the measured Retinal nerve fiber layer thickness around Optic nerve head at Macula for the OCT function of the NIDEK TONOREF III.	1 day
Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT	Precision (repeatability) of the measured Thickness of the Cornea for the OCT function of the NIDEK TONOREF III.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Nidek Co. LTD.
• Investigators: Study Director: Tadakazu Ichimura, Nidek Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Corneal Diseases
• Other Study ID Numbers: Nidek Mirante-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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