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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIDEK Mirante Comparison - Normal | Experimental | Subjects without any current ocular pathology other than cataract in either eye |
|
| NIDEK Mirante Comparison - Retina | Experimental | Subjects diagnosed with retinal pathology |
|
| NIDEK Mirante Comparison - Glaucoma | Experimental | Subjects who have been diagnosed with glaucoma |
|
| NIDEK Mirante Comparison - Corneal disease | Experimental | Subjects with corneal pathologies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nidek Mirante | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria - Normal Group:
Exclusion Criteria - Normal Group:
Inclusion Criteria - Glaucoma Group:
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;
Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date;
Subjects who agree to participate in the study;
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:
Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit;
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:
Exclusion Criteria - Glaucoma Group:
Inclusion Criteria - Retinal Disease Group:
Exclusion Criteria - Retinal Disease Group
Inclusion Criteria - Corneal Group
Exclusion Criteria - Corneal Group
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| Name | Affiliation | Role |
|---|---|---|
| Tadakazu Ichimura | Nidek Co. LTD. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01840 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NIDEK Mirante Comparison - Normal | Subjects without any current ocular pathology other than cataract in either eye |
| FG001 | NIDEK Mirante Comparison - Retina | Subjects diagnosed with retinal pathology |
| FG002 | NIDEK Mirante Comparison - Glaucoma | Subjects who have been diagnosed with glaucoma |
| FG003 | NIDEK Mirante Comparison - Corneal Disease | Subjects who have been diagnosed with corneal pathologies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NIDEK Mirante Comparison - Normal | Subjects without any current ocular pathology other than cataract in either eye |
| BG001 | NIDEK Mirante Comparison - Retina | Subjects diagnosed with retinal pathology |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The cornea arm/group was omitted because this group did not measure the macular thickness. | Posted | Mean | Standard Deviation | μm | 1 day | eyes | eyes |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normals | 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. 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tadakazu Ichimura | Nidek.co., ltd. | +81-533-67-8904 | tadakazu_ichimura@nidek.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2020 | May 25, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D012164 | Retinal Diseases |
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Optovue RTVue XR Avanti | Device | 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. |
|
| Optos P200DTx | Device | 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. |
|
| 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 |
| BG002 | NIDEK Mirante Comparison - Glaucoma | Subjects who have been diagnosed with glaucoma |
| BG003 | NIDEK Mirante Comparison - Corneal Disease | Subjects who have been diagnosed with corneal pathologies |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | NIDEK Mirante Comparison - Glaucoma | Subjects who have been diagnosed with glaucoma |
|
|
| 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. | The retina and cornea arm/group were omitted because this group did not measure the retinal nerve fiber layer thickness. | Posted | Mean | Standard Deviation | µm | 1 day | eyes | eyes |
|
|
|
| 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. | The retina and glaucoma arm/group were omitted because this group did not measure the corneal thickness. | Posted | Mean | Standard Deviation | µm | 1 day | eyes | eyes |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day | eyes | eyes |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 day | eyes | eyes |
|
|
|
| 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. | The cornea arm/group was omitted because this group did not measure the Full retinal thickness at Macula. | Posted | Number | %CV Repeatability | 1 day | eyes | eyes |
|
|
|
| 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. | 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. | Posted | Number | %CV Repeatability | 1 day | eyes | eyes |
|
|
|
| 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. | The retina and glaucoma arm/group were omitted because these groups did not measure the thickness of the cornea. | Posted | Number | %CV Repeatability | 1 day | eyes | eyes |
|
|
|
| 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. | Posted | Count of Units | eyes | 1 day | eyes | eyes |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Retina | 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. 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. 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. | 0 | 47 | 0 | 47 | 0 | 47 |
| EG002 | Glaucoma | 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. 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. 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. | 0 | 46 | 0 | 46 | 0 | 46 |
| EG003 | Corneal Disease | 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. 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| S/I Superior |
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| TSNIT Temporal |
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| TSNIT Superior |
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| TSNIT Nasal |
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| TSNIT Inferior |
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| Horizontal C/D Ratio |
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| Vertical C/D Ratio |
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| Disc Area |
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| Cup Area |
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| SLO Color Fundus: Overall Quality |
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| SLO B-FAF: Clinical Utility |
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| SLO B-FAF: Overall Quality |
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| SLO G-FAF: Clinical Utility |
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| SLO G-FAF: Overall Quality |
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| eyes |
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| Overall Utility |
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| Title | Measurements |
|---|---|
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| Inner Superior |
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| Inner Nasal |
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| Inner Inferior |
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| Outer Temporal |
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| Outer Superior |
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| Outer Nasal |
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| Outer Inferior |
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| TSNIT Superior |
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| TSNIT Temporal |
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| Whole Chart |
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| S/I Inferior |
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| S/I Superior |
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| Horizontal C/D Ratio |
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| Vertical C/D Ratio |
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| Disc Area |
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| Cup Area |
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| eyes |
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