Trial Outcomes & Findings for Agreement and Precision Study of the Nidek Mirante (NCT NCT04318132)
NCT ID: NCT04318132
Last Updated: 2023-08-24
Results Overview
Agreement of the measured Macular thickness (μm) between the test device and the predicate device for the OCT function of NIDEK Mirante.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
1 day
Results posted on
2023-08-24
Participant Flow
Unit of analysis: eyes
Participant milestones
| Measure |
NIDEK Mirante Comparison - Normal
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
45 45
|
47 47
|
46 46
|
32 32
|
|
Overall Study
COMPLETED
|
45 45
|
47 47
|
43 43
|
32 32
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
3 3
|
0 0
|
Reasons for withdrawal
| Measure |
NIDEK Mirante Comparison - Normal
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Agreement and Precision Study of the Nidek Mirante
Baseline characteristics by cohort
| Measure |
NIDEK Mirante Comparison - Normal
n=45 Participants
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=47 Participants
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=46 Participants
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
n=32 Participants
Subjects who have been diagnosed with corneal pathologies
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 15.36 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
65.1 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 15.09 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 16.05 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
158 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The cornea arm/group was omitted because this group did not measure the macular thickness.
Agreement of the measured Macular thickness (μm) between the test device and the predicate device for the OCT function of NIDEK Mirante.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=45 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=46 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=43 eyes
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Temporal
|
19.200 μm
Standard Deviation 6.4194
|
17.065 μm
Standard Deviation 4.2079
|
17.047 μm
Standard Deviation 6.2104
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Temporal
|
10.267 μm
Standard Deviation 6.5796
|
9.587 μm
Standard Deviation 5.2560
|
9.628 μm
Standard Deviation 5.3275
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Superior
|
11.311 μm
Standard Deviation 5.4306
|
10.370 μm
Standard Deviation 6.0309
|
10.767 μm
Standard Deviation 6.2786
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Nasal
|
12.733 μm
Standard Deviation 6.0317
|
10.522 μm
Standard Deviation 6.4524
|
11.023 μm
Standard Deviation 5.8614
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Inferior
|
13.844 μm
Standard Deviation 5.5757
|
11.957 μm
Standard Deviation 7.4951
|
12.581 μm
Standard Deviation 6.3555
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Center
|
10.658 μm
Standard Deviation 4.3789
|
11.032 μm
Standard Deviation 6.9749
|
11.415 μm
Standard Deviation 4.8615
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Superior
|
22.889 μm
Standard Deviation 6.0386
|
18.870 μm
Standard Deviation 3.8965
|
20.628 μm
Standard Deviation 5.8879
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Nasal
|
21.911 μm
Standard Deviation 6.0521
|
19.043 μm
Standard Deviation 4.5896
|
19.721 μm
Standard Deviation 6.1965
|
—
|
|
Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Inferior
|
22.267 μm
Standard Deviation 4.7645
|
19.739 μm
Standard Deviation 5.4014
|
19.163 μm
Standard Deviation 7.3870
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The retina and cornea arm/group were omitted because this group did not measure the retinal nerve fiber layer thickness.
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.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=45 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=43 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
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
|
7.536 µm
Standard Deviation 4.7895
|
—
|
—
|
|
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
|
7.631 µm
Standard Deviation 7.0398
|
—
|
—
|
|
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
|
-0.010 µm
Standard Deviation 0.2491
|
—
|
—
|
|
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
|
7.426 µm
Standard Deviation 7.1255
|
—
|
—
|
|
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
|
1.965 µm
Standard Deviation 10.0886
|
—
|
—
|
|
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
|
5.928 µm
Standard Deviation 10.1354
|
—
|
—
|
|
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
|
12.395 µm
Standard Deviation 7.7614
|
—
|
—
|
|
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
|
9.854 µm
Standard Deviation 8.5394
|
—
|
—
|
|
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
|
-0.061 µm
Standard Deviation 0.1358
|
—
|
—
|
|
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
|
-0.056 µm
Standard Deviation 0.1401
|
—
|
—
|
|
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
|
0.210 µm
Standard Deviation 0.2919
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The retina and glaucoma arm/group were omitted because this group did not measure the corneal thickness.
Agreement of the measured Corneal thickness between the test device and the predicate device for the OCT function of NIDEK Mirante.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=45 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=19 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
|
16.511 µm
Standard Deviation 3.9117
|
14.842 µm
Standard Deviation 8.3084
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
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.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=45 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=47 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=43 eyes
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
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
|
2.9 score on a scale
Standard Deviation 0.27
|
3.0 score on a scale
Standard Deviation 0.11
|
—
|
|
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
|
2.8 score on a scale
Standard Deviation 0.37
|
3.0 score on a scale
Standard Deviation 0.11
|
—
|
|
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
|
2.3 score on a scale
Standard Deviation 0.62
|
2.6 score on a scale
Standard Deviation 0.41
|
—
|
|
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
|
2.2 score on a scale
Standard Deviation 0.67
|
2.5 score on a scale
Standard Deviation 0.49
|
—
|
|
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
|
2.4 score on a scale
Standard Deviation 0.54
|
2.6 score on a scale
Standard Deviation 0.47
|
—
|
|
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
|
2.4 score on a scale
Standard Deviation 0.53
|
2.6 score on a scale
Standard Deviation 0.41
|
—
|
PRIMARY outcome
Timeframe: 1 dayAgreement 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.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=44 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=46 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=42 eyes
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
n=32 eyes
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
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
|
2.2 score on a scale
Standard Deviation 0.42
|
2.3 score on a scale
Standard Deviation 0.43
|
2.2 score on a scale
Standard Deviation 0.56
|
|
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
|
2.1 score on a scale
Standard Deviation 0.45
|
2.2 score on a scale
Standard Deviation 0.45
|
2.1 score on a scale
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The cornea arm/group was omitted because this group did not measure the Full retinal thickness at Macula.
Precision (repeatability) of the measured Full retinal thickness at Macula for the OCT function of the NIDEK TONOREF III.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=44 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=44 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=40 eyes
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Center
|
1.034 %CV Repeatability
|
1.163 %CV Repeatability
|
1.031 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Temporal
|
0.425 %CV Repeatability
|
0.863 %CV Repeatability
|
0.433 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Superior
|
0.606 %CV Repeatability
|
0.701 %CV Repeatability
|
0.531 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Nasal
|
0.465 %CV Repeatability
|
0.608 %CV Repeatability
|
0.441 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Inner Inferior
|
0.502 %CV Repeatability
|
0.806 %CV Repeatability
|
0.678 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Superior
|
0.682 %CV Repeatability
|
0.776 %CV Repeatability
|
0.784 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Nasal
|
0.415 %CV Repeatability
|
0.593 %CV Repeatability
|
0.528 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Inferior
|
0.865 %CV Repeatability
|
1.075 %CV Repeatability
|
1.012 %CV Repeatability
|
—
|
|
Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Outer Temporal
|
0.764 %CV Repeatability
|
0.971 %CV Repeatability
|
0.786 %CV Repeatability
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 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.
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.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=40 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=34 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
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
|
6.015 %CV Repeatability
|
—
|
—
|
|
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
|
6.495 %CV Repeatability
|
—
|
—
|
|
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
|
7.703 %CV Repeatability
|
—
|
—
|
|
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
|
3.531 %CV Repeatability
|
—
|
—
|
|
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
|
5.563 %CV Repeatability
|
—
|
—
|
|
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
|
7.553 %CV Repeatability
|
—
|
—
|
|
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
|
10.047 %CV Repeatability
|
—
|
—
|
|
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
|
7.814 %CV Repeatability
|
—
|
—
|
|
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
|
5.900 %CV Repeatability
|
—
|
—
|
|
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
|
6.725 %CV Repeatability
|
—
|
—
|
|
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
|
5.912 %CV Repeatability
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 dayPopulation: The retina and glaucoma arm/group were omitted because these groups did not measure the thickness of the cornea.
Precision (repeatability) of the measured Thickness of the Cornea for the OCT function of the NIDEK TONOREF III.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=42 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=18 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
|
0.535 %CV Repeatability
|
0.878 %CV Repeatability
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 dayAn 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.
Outcome measures
| Measure |
NIDEK Mirante Comparison - Normal
n=45 eyes
Subjects without any current ocular pathology other than cataract in either eye
|
NIDEK Mirante Comparison - Retina
n=47 eyes
Subjects diagnosed with retinal pathology
|
NIDEK Mirante Comparison - Glaucoma
n=46 eyes
Subjects who have been diagnosed with glaucoma
|
NIDEK Mirante Comparison - Corneal Disease
n=32 eyes
Subjects who have been diagnosed with corneal pathologies
|
|---|---|---|---|---|
|
Adverse Events
|
0 eyes
|
0 eyes
|
0 eyes
|
0 eyes
|
Adverse Events
Normals
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Retina
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Glaucoma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corneal Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place