Corneal Disease, Glaucoma, Retinal Disease
Conditions
Brief summary
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.
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.
Interventions
DEVICENidek 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.
DEVICEOptovue 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.
DEVICEOptos 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.
Sponsors
Nidek Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | Precision (repeatability) of the measured Thickness of the Cornea for the OCT function of the NIDEK TONOREF III. |
| Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | Agreement of the measured Macular thickness (μm) between the test device and the predicate device for the OCT function of NIDEK Mirante. |
| Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | 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. |
| Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | Agreement of the measured Corneal thickness between the test device and the predicate device for the OCT function of NIDEK Mirante. |
| Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | 1 day | 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. |
| Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | 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. |
| Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | Precision (repeatability) of the measured Full retinal thickness at Macula for the OCT function of the NIDEK TONOREF III. |
| Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 day | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NIDEK Mirante Comparison - Normal Subjects without any current ocular pathology other than cataract in either eye | 45 |
| NIDEK Mirante Comparison - Retina Subjects diagnosed with retinal pathology | 47 |
| NIDEK Mirante Comparison - Glaucoma Subjects who have been diagnosed with glaucoma | 46 |
| NIDEK Mirante Comparison - Corneal Disease Subjects who have been diagnosed with corneal pathologies | 32 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | NIDEK Mirante Comparison - Retina | NIDEK Mirante Comparison - Glaucoma | NIDEK Mirante Comparison - Corneal Disease | NIDEK Mirante Comparison - Normal | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 28 Participants | 11 Participants | 4 Participants | 74 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 21 Participants | 41 Participants | 96 Participants |
| Age, Continuous | 69.7 years STANDARD_DEVIATION 11.23 | 65.1 years STANDARD_DEVIATION 9.2 | 55.4 years STANDARD_DEVIATION 15.09 | 44.9 years STANDARD_DEVIATION 15.36 | 59.2 years STANDARD_DEVIATION 16.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 46 Participants | 42 Participants | 29 Participants | 41 Participants | 158 Participants |
| Region of Enrollment United States | 47 Participants | 46 Participants | 32 Participants | 45 Participants | 170 Participants |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 20 Participants | 28 Participants | 99 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 12 Participants | 17 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 47 | 0 / 46 | 0 / 32 |
| other Total, other adverse events | 0 / 45 | 0 / 47 | 0 / 46 | 0 / 32 |
| serious Total, serious adverse events | 0 / 45 | 0 / 47 | 0 / 46 | 0 / 32 |
Outcome results
Primary
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.
Time frame: 1 day
Population: The retina and glaucoma arm/group were omitted because this group did not measure the corneal thickness.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 16.511 µm | Standard Deviation 3.9117 |
| NIDEK Mirante Comparison - Retina | Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 14.842 µm | Standard Deviation 8.3084 |
Primary
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.
Time frame: 1 day
Population: The cornea arm/group was omitted because this group did not measure the macular thickness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 21.911 μm | Standard Deviation 6.0521 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 13.844 μm | Standard Deviation 5.5757 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 10.267 μm | Standard Deviation 6.5796 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 22.267 μm | Standard Deviation 4.7645 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 10.658 μm | Standard Deviation 4.3789 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 12.733 μm | Standard Deviation 6.0317 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 22.889 μm | Standard Deviation 6.0386 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 19.200 μm | Standard Deviation 6.4194 |
| NIDEK Mirante Comparison - Normal | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 11.311 μm | Standard Deviation 5.4306 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 19.739 μm | Standard Deviation 5.4014 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 11.032 μm | Standard Deviation 6.9749 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 17.065 μm | Standard Deviation 4.2079 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 18.870 μm | Standard Deviation 3.8965 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 19.043 μm | Standard Deviation 4.5896 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 9.587 μm | Standard Deviation 5.256 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 10.370 μm | Standard Deviation 6.0309 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 10.522 μm | Standard Deviation 6.4524 |
| NIDEK Mirante Comparison - Retina | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 11.957 μm | Standard Deviation 7.4951 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 20.628 μm | Standard Deviation 5.8879 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 11.415 μm | Standard Deviation 4.8615 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 10.767 μm | Standard Deviation 6.2786 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 17.047 μm | Standard Deviation 6.2104 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 12.581 μm | Standard Deviation 6.3555 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 19.163 μm | Standard Deviation 7.387 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 19.721 μm | Standard Deviation 6.1965 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 11.023 μm | Standard Deviation 5.8614 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 9.628 μm | Standard Deviation 5.3275 |
Primary
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.
Time frame: 1 day
Population: The retina and cornea arm/group were omitted because this group did not measure the retinal nerve fiber layer thickness.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Temporal | -4.515 µm | Standard Deviation 8.1383 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Inferior | 17.211 µm | Standard Deviation 8.6067 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Superior | 8.554 µm | Standard Deviation 5.5885 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Horizontal C/D Ratio | 0.018 µm | Standard Deviation 0.1977 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Superior | 11.762 µm | Standard Deviation 8.8701 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Vertical C/D Ratio | 0.030 µm | Standard Deviation 0.1944 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Inferior | 9.725 µm | Standard Deviation 5.3925 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Disc Area | 0.271 µm | Standard Deviation 0.1995 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Nasal | 12.250 µm | Standard Deviation 8.7671 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Cup Area | 0.055 µm | Standard Deviation 0.2236 |
| NIDEK Mirante Comparison - Normal | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Whole Chart | 9.233 µm | Standard Deviation 4.3936 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Cup Area | -0.010 µm | Standard Deviation 0.2491 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Whole Chart | 7.536 µm | Standard Deviation 4.7895 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Inferior | 7.631 µm | Standard Deviation 7.0398 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Superior | 7.426 µm | Standard Deviation 7.1255 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Temporal | 1.965 µm | Standard Deviation 10.0886 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Superior | 5.928 µm | Standard Deviation 10.1354 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Nasal | 12.395 µm | Standard Deviation 7.7614 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Inferior | 9.854 µm | Standard Deviation 8.5394 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Horizontal C/D Ratio | -0.061 µm | Standard Deviation 0.1358 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Vertical C/D Ratio | -0.056 µm | Standard Deviation 0.1401 |
| NIDEK Mirante Comparison - Retina | Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Disc Area | 0.210 µm | Standard Deviation 0.2919 |
Primary
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.
Time frame: 1 day
Population: Some patients could not be captured acceptable SLO images. The cornea arm/group was omitted because this group was not included in the SLO images assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Clinical Utility | 2.9 score on a scale | Standard Deviation 0.21 |
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Overall Quality | 3.0 score on a scale | Standard Deviation 0.17 |
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Clinical Utility | 2.6 score on a scale | Standard Deviation 0.48 |
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Overall Quality | 2.6 score on a scale | Standard Deviation 0.52 |
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Clinical Utility | 2.4 score on a scale | Standard Deviation 0.61 |
| NIDEK Mirante Comparison - Normal | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Overall Quality | 2.4 score on a scale | Standard Deviation 0.65 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Overall Quality | 2.4 score on a scale | Standard Deviation 0.54 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Clinical Utility | 2.9 score on a scale | Standard Deviation 0.27 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Overall Quality | 2.2 score on a scale | Standard Deviation 0.67 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Clinical Utility | 2.4 score on a scale | Standard Deviation 0.53 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Overall Quality | 2.8 score on a scale | Standard Deviation 0.37 |
| NIDEK Mirante Comparison - Retina | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Clinical Utility | 2.3 score on a scale | Standard Deviation 0.62 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Overall Quality | 3.0 score on a scale | Standard Deviation 0.11 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Clinical Utility | 2.6 score on a scale | Standard Deviation 0.41 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Overall Quality | 2.6 score on a scale | Standard Deviation 0.47 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO B-FAF: Overall Quality | 2.5 score on a scale | Standard Deviation 0.49 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO Color Fundus: Clinical Utility | 3.0 score on a scale | Standard Deviation 0.11 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx | SLO G-FAF: Clinical Utility | 2.6 score on a scale | Standard Deviation 0.41 |
Primary
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.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Clinical Utility | 2.4 score on a scale | Standard Deviation 0.39 |
| NIDEK Mirante Comparison - Normal | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Overall Utility | 2.2 score on a scale | Standard Deviation 0.47 |
| NIDEK Mirante Comparison - Retina | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Overall Utility | 2.1 score on a scale | Standard Deviation 0.45 |
| NIDEK Mirante Comparison - Retina | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Clinical Utility | 2.2 score on a scale | Standard Deviation 0.42 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Clinical Utility | 2.3 score on a scale | Standard Deviation 0.43 |
| NIDEK Mirante Comparison - Glaucoma | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Overall Utility | 2.2 score on a scale | Standard Deviation 0.45 |
| NIDEK Mirante Comparison - Corneal Disease | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Clinical Utility | 2.2 score on a scale | Standard Deviation 0.56 |
| NIDEK Mirante Comparison - Corneal Disease | Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT | Overall Utility | 2.1 score on a scale | Standard Deviation 0.54 |
Primary
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.
Time frame: 1 day
Population: The retina and glaucoma arm/group were omitted because these groups did not measure the thickness of the cornea.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NIDEK Mirante Comparison - Normal | Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 0.535 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | 0.878 %CV Repeatability |
Primary
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.
Time frame: 1 day
Population: The cornea arm/group was omitted because this group did not measure the Full retinal thickness at Macula.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 0.465 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 0.865 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 0.764 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 0.502 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 1.034 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 0.415 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 0.606 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 0.425 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 0.682 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 0.806 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 1.163 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 0.863 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 0.701 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 0.608 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 0.971 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 0.776 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 0.593 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 1.075 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Superior | 0.531 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Center | 1.031 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Superior | 0.784 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Temporal | 0.433 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Inferior | 1.012 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Inferior | 0.678 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Inner Nasal | 0.441 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Nasal | 0.528 %CV Repeatability |
| NIDEK Mirante Comparison - Glaucoma | Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Outer Temporal | 0.786 %CV Repeatability |
Primary
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.
Time frame: 1 day
Population: The retina and cornea arm/group were omitted because these groups did not measure the retinal nerve fiber layer thickness around the Optic nerve head.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Temporal | 4.514 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Superior | 3.550 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Superior | 3.708 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Horizontal C/D Ratio | 9.380 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Whole Chart | 2.268 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Vertical C/D Ratio | 7.394 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Nasal | 6.730 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Disc Area | 5.892 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Inferior | 3.950 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Cup Area | 14.148 %CV Repeatability |
| NIDEK Mirante Comparison - Normal | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Inferior | 3.813 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Cup Area | 10.047 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Inferior | 6.015 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Nasal | 7.814 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Superior | 6.495 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | TSNIT Temporal | 7.703 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Whole Chart | 3.531 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Inferior | 5.563 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | S/I Superior | 5.900 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Horizontal C/D Ratio | 6.725 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Vertical C/D Ratio | 5.912 %CV Repeatability |
| NIDEK Mirante Comparison - Retina | Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT | Disc Area | 7.553 %CV Repeatability |
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.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| NIDEK Mirante Comparison - Normal | Adverse Events | 0 eyes |
| NIDEK Mirante Comparison - Retina | Adverse Events | 0 eyes |
| NIDEK Mirante Comparison - Glaucoma | Adverse Events | 0 eyes |
| NIDEK Mirante Comparison - Corneal Disease | Adverse Events | 0 eyes |