GlaucomaNCT04318132

Agreement and Precision Study of the Nidek Mirante

A study testing Nidek Mirante, Optovue RTVue XR Avanti and Optos P200DTx in people with Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Glaucoma, Retinal Disease, Corneal Disease
What is being tested?: Nidek Mirante, Optovue RTVue XR Avanti and Optos P200DTx
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteUnited States
Study dates: 25 Jan 2020to 30 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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;
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 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;
Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in both eyes on the date the study visit.
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;

Show all 25Show fewer

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:
Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; or
Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue;
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:
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
Glaucoma hemi-field test "outside normal limits."
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;
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 with a current BSCVA of 20/400 or better in the retinal disease study eye(s) at the study visit;
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.
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;
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 with a current BSCVA of 20/400 or better in the study eye(s) at the study visit;
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.

Who cannot join

Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye;
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;
Subjects with (or history of) leukemia, dementia or multiple sclerosis;
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.
Subjects unable to tolerate ophthalmic imaging;

Show all 19Show fewer

Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the glaucoma study eye(s);
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;
Subjects with (or history of) leukemia, dementia or multiple sclerosis;
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.
Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
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;
Subjects with (or history of) leukemia, dementia or multiple sclerosis;
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.
Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in the study eye;
Subjects with (or history of) leukemia, dementia or multiple sclerosis;
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Andover Eye Associates
Andover, Massachusetts, 01840

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Glaucoma, Retinal Disease, Corneal Disease
Being tested: Nidek Mirante, Optovue RTVue XR Avanti, Optos P200DTx
Medical subject headings: Glaucoma, Retinal Diseases, Corneal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nidek MiranteDevice
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 AvantiDevice
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 P200DTxDevice
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.

Study groups in NCT04318132
Study group	Role	What they receive
NIDEK Mirante Comparison - Normal	Experimental	Subjects without any current ocular pathology other than cataract in either eye Receives: Device: Nidek Mirante; Device: Optovue RTVue XR Avanti; Device: Optos P200DTx
NIDEK Mirante Comparison - Retina	Experimental	Subjects diagnosed with retinal pathology Receives: Device: Nidek Mirante; Device: Optovue RTVue XR Avanti; Device: Optos P200DTx
NIDEK Mirante Comparison - Glaucoma	Experimental	Subjects who have been diagnosed with glaucoma Receives: Device: Nidek Mirante; Device: Optovue RTVue XR Avanti; Device: Optos P200DTx
NIDEK Mirante Comparison - Corneal disease	Experimental	Subjects with corneal pathologies Receives: Device: Nidek Mirante; Device: Optovue RTVue XR Avanti

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day

Secondary outcomes (1)

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.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 202030 Dec 2021

First posted23 Mar 2020
Study start25 Jan 2020
Primary completion30 Dec 2021
Study completion30 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04318132
Sponsor's protocol ID: Nidek Mirante-001
Status last verified: Jul 2023
First submitted: 12 Feb 2020
Last updated: 24 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04318132
Acronym / sponsor ID: Nidek Mirante-001
Conditions: Glaucoma, Retinal Disease, Corneal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Nidek Co. LTD.Industry (pharma, biotech, devices)
Study start: 25 Jan 2020 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 30 Dec 2021 (actual)
First posted: 23 Mar 2020 (actual)
Results: Posted 24 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
NIDEK Mirante Comparison - Normal	Experimental	Device: Nidek Mirante, Device: Optovue RTVue XR Avanti, Device: Optos P200DTxSubjects without any current ocular pathology other than cataract in either eye
NIDEK Mirante Comparison - Retina	Experimental	Device: Nidek Mirante, Device: Optovue RTVue XR Avanti, Device: Optos P200DTxSubjects diagnosed with retinal pathology
NIDEK Mirante Comparison - Glaucoma	Experimental	Device: Nidek Mirante, Device: Optovue RTVue XR Avanti, Device: Optos P200DTxSubjects who have been diagnosed with glaucoma
NIDEK Mirante Comparison - Corneal disease	Experimental	Device: Nidek Mirante, Device: Optovue RTVue XR AvantiSubjects with corneal pathologies

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

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;
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 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;
Subjects with current best-spectacle-corrected visual acuity (BSCVA) of 20/40 or better in both eyes on the date the study visit.

Key exclusion criteria (19 listed)

Subjects unable to tolerate ophthalmic imaging;
Subjects with ocular media not sufficiently clear to obtain acceptable OCT images in either eye;
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;
Subjects with (or history of) leukemia, dementia or multiple sclerosis;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nidek MiranteThe 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	NIDEK Mirante Comparison - Corneal disease, NIDEK Mirante Comparison - Glaucoma, NIDEK Mirante Comparison - Normal, NIDEK Mirante Comparison - Retina
Optovue RTVue XR AvantiThe 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	NIDEK Mirante Comparison - Corneal disease, NIDEK Mirante Comparison - Glaucoma, NIDEK Mirante Comparison - Normal, NIDEK Mirante Comparison - Retina
Optos P200DTxThe 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.	Device	NIDEK Mirante Comparison - Glaucoma, NIDEK Mirante Comparison - Normal, NIDEK Mirante Comparison - Retina

Primary outcome

Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT
Time frame: 1 day
Precision (repeatability) of the measured Thickness of the Cornea for the OCT function of the NIDEK TONOREF III.

1 secondary outcome

Adverse Events
Time frame: 1 day

Results and safety

Results posted to the registry on 24 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NIDEK Mirante Comparison - Normal	45	45
NIDEK Mirante Comparison - Retina	47	47
NIDEK Mirante Comparison - Glaucoma	46	43
NIDEK Mirante Comparison - Corneal Disease	32	32

Primary outcome: Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

Time frame: 1 day. Mean (Standard Deviation). Unit: μm

Measure	NIDEK Mirante Comparison - Normal n = 45	NIDEK Mirante Comparison - Retina n = 46	NIDEK Mirante Comparison - Glaucoma n = 43
Center	10.658 (4.3789)	11.032 (6.9749)	11.415 (4.8615)
Inner Temporal	19.200 (6.4194)	17.065 (4.2079)	17.047 (6.2104)
Inner Superior	22.889 (6.0386)	18.870 (3.8965)	20.628 (5.8879)
Inner Nasal	21.911 (6.0521)	19.043 (4.5896)	19.721 (6.1965)
Inner Inferior	22.267 (4.7645)	19.739 (5.4014)	19.163 (7.3870)
Outer Temporal	10.267 (6.5796)	9.587 (5.2560)	9.628 (5.3275)
Outer Superior	11.311 (5.4306)	10.370 (6.0309)	10.767 (6.2786)
Outer Nasal	12.733 (6.0317)	10.522 (6.4524)	11.023 (5.8614)

Population analysed: The cornea arm/group was omitted because this group did not measure the macular thickness.

Primary outcome: Agreement of Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

Time frame: 1 day. Mean (Standard Deviation). Unit: µm

Measure	NIDEK Mirante Comparison - Normal n = 45	NIDEK Mirante Comparison - Glaucoma n = 43
Whole Chart	9.233 (4.3936)	7.536 (4.7895)
S/I Inferior	9.725 (5.3925)	7.631 (7.0398)
S/I Superior	8.554 (5.5885)	7.426 (7.1255)
TSNIT Temporal	-4.515 (8.1383)	1.965 (10.0886)
TSNIT Superior	11.762 (8.8701)	5.928 (10.1354)
TSNIT Nasal	12.250 (8.7671)	12.395 (7.7614)
TSNIT Inferior	17.211 (8.6067)	9.854 (8.5394)
Horizontal C/D Ratio	0.018 (0.1977)	-0.061 (0.1358)

Population analysed: The retina and cornea arm/group were omitted because this group did not measure the retinal nerve fiber layer thickness.

Primary outcome: Agreement of Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

Time frame: 1 day. Mean (Standard Deviation). Unit: µm

Measure	NIDEK Mirante Comparison - Normal n = 45	NIDEK Mirante Comparison - Corneal Disease n = 19
Value	16.511 (3.9117)	14.842 (8.3084)

Population analysed: The retina and glaucoma arm/group were omitted because this group did not measure the corneal thickness.

Primary outcome: Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx

Time frame: 1 day. Mean (Standard Deviation). Unit: score on a scale

Measure	NIDEK Mirante Comparison - Normal n = 45	NIDEK Mirante Comparison - Retina n = 47	NIDEK Mirante Comparison - Glaucoma n = 43
SLO Color Fundus: Clinical Utility	2.9 (0.21)	2.9 (0.27)	3.0 (0.11)
SLO Color Fundus: Overall Quality	3.0 (0.17)	2.8 (0.37)	3.0 (0.11)
SLO B-FAF: Clinical Utility	2.6 (0.48)	2.3 (0.62)	2.6 (0.41)
SLO B-FAF: Overall Quality	2.6 (0.52)	2.2 (0.67)	2.5 (0.49)
SLO G-FAF: Clinical Utility	2.4 (0.61)	2.4 (0.53)	2.6 (0.41)
SLO G-FAF: Overall Quality	2.4 (0.65)	2.4 (0.54)	2.6 (0.47)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normals	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Retina	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Glaucoma	0 of 46 (0%)	0 of 46 (0%)	0 of 46
Corneal Disease	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tadakazu Ichimura study director

Nidek Co. LTD.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nidek Mirante, Optovue RTVue XR Avanti and Optos P200DTx in people with Glaucoma and Retinal Disease, run by Nidek Co. LTD. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement of Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04318132.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023; AzTrials last refreshed its copy on 7 Nov 2026.