NCT04318132

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.9 years

First QC Date

February 12, 2020

Results QC Date

March 28, 2023

Last Update Submit

July 31, 2023

Conditions

GlaucomaRetinal DiseaseCorneal Disease

Outcome Measures

Primary Outcomes (8)

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

    Agreement of the measured Macular thickness (μm) between the test device and the predicate device for the OCT function of NIDEK Mirante.

    1 day

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

    Agreement of the measured Retinal nerve fiber layer thickness around Optic nerve head between the test device and the predicate device for the OCT function of NIDEK Mirante.

    1 day

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

    Agreement of the measured Corneal thickness between the test device and the predicate device for the OCT function of NIDEK Mirante.

    1 day

  • Agreement of SLO Image Quality (Likert Scale) for Nidek Mirante and OPTOS P200DTx

    Agreement of the SLO Image quality between the test device and the predicate device for the SLO function of NIDEK Mirante. The image quality of is graded Clinical Utility and Overall Utility for each image patterns (SLO Color Fundus, SLO B-FAF and SLO G-FAF) on a Likert scale. The grading used the 0-3 point scale, and higher scores mean a better image quality.

    1 day

  • Agreement of the ACA Image Quality (Likert Scale) for Nidek Mirante and Optovue RTVue XR Avanti OCT

    Agreement of the ACA Image quality between the test device and the predicate device for the OCT function of NIDEK Mirante. The image quality of is graded Clinical Utility and Overall Utility on a Likert scale. The grading used the 0-3 point scale, and higher scores mean a better image quality.

    1 day

  • Precision of the Macular Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

    Precision (repeatability) of the measured Full retinal thickness at Macula for the OCT function of the NIDEK TONOREF III.

    1 day

  • Precision of the Retinal Nerve Fiber Layer Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

    Precision (repeatability) of the measured Retinal nerve fiber layer thickness around Optic nerve head at Macula for the OCT function of the NIDEK TONOREF III.

    1 day

  • Precision of the Corneal Thickness (μm) Measurement for Nidek Mirante and Optovue RTVue XR Avanti OCT

    Precision (repeatability) of the measured Thickness of the Cornea for the OCT function of the NIDEK TONOREF III.

    1 day

Secondary Outcomes (1)

  • Adverse Events

    1 day

Study Arms (4)

NIDEK Mirante Comparison - Normal

EXPERIMENTAL

Subjects without any current ocular pathology other than cataract in either eye

Device: Nidek MiranteDevice: Optovue RTVue XR AvantiDevice: Optos P200DTx

NIDEK Mirante Comparison - Retina

EXPERIMENTAL

Subjects diagnosed with retinal pathology

Device: Nidek MiranteDevice: Optovue RTVue XR AvantiDevice: Optos P200DTx

NIDEK Mirante Comparison - Glaucoma

EXPERIMENTAL

Subjects who have been diagnosed with glaucoma

Device: Nidek MiranteDevice: Optovue RTVue XR AvantiDevice: Optos P200DTx

NIDEK Mirante Comparison - Corneal disease

EXPERIMENTAL

Subjects with corneal pathologies

Device: Nidek MiranteDevice: Optovue RTVue XR Avanti

Interventions

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.

NIDEK Mirante Comparison - Corneal diseaseNIDEK Mirante Comparison - GlaucomaNIDEK Mirante Comparison - NormalNIDEK Mirante Comparison - Retina
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.

NIDEK Mirante Comparison - Corneal diseaseNIDEK Mirante Comparison - GlaucomaNIDEK Mirante Comparison - NormalNIDEK Mirante Comparison - Retina
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.

NIDEK Mirante Comparison - GlaucomaNIDEK Mirante Comparison - NormalNIDEK Mirante Comparison - Retina

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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:
  • 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."
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01840, United States

Location

MeSH Terms

Conditions

GlaucomaRetinal DiseasesCorneal Diseases

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Tadakazu Ichimura
Organization
Nidek.co., ltd.
tadakazu_ichimura@nidek.co.jp
+81-533-67-8904

Study Officials

  • Tadakazu Ichimura

    Nidek Co. LTD.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2020

First Posted

March 23, 2020

Study Start

January 25, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 24, 2023

Results First Posted

August 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)