Normal Healthy Subjects With No Known Ocular DiseasesNCT02277119

Clinical Study of the Optic Disc Parameters

A study testing Maestro and iVue in people with Normal Healthy Subjects With No Known Ocular Diseases and Glaucomatous Eyes, run by Topcon Medical Systems, Inc. at 2 sites 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

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
What is being tested?: Maestro and iVue
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 2 sitesUnited States
Study dates: Oct 2014to Feb 2015
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects 18 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects presenting at the site with normal eyes (eyes without pathology)
lOPs 21mmHg bilaterally
BCVA 20/40 or better (each eye)
Both eyes must be free of eye disease

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Subjects 18 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects presenting at the site with glaucoma
BCVA 20/40 or better in the study eye
HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5% in the study eye
Subjects 18 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects presenting at the site with retinal disease
lOP <= 21mmHg in the study eye
BCVA 20/400 or better in the study eye
Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others

Who cannot join

Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images
HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses> 33% or false positives > 25%, or false negatives > 25%
Presence of any ocular pathology except for cataract

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Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
Narrow angle
History of leukemia, dementia or multiple sclerosis
Concomitant use of hydroxychloroquine and chloroquine
Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images
HFA visual field (24-2 Sita Standard, white on white) result unreliable, defined as fixation losses > 33% or false positives > 25%, or false negatives > 25% in the study eye
Presence of any ocular pathology except glaucoma in the study eye
Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye
History of leukemia, dementia or multiple sclerosis
Concomitant use of hydroxychloroquine and chloroquine
Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images
Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning in the study eye
Narrow angle in the study eye
History of leukemia, dementia or multiple sclerosis
Concomitant use of hydroxychloroquine and chloroquine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

SUNY College of Optometry
New York, New York, 10036
Western University of Health Sciences
Pomona, California, 91716

Other trials in United States

About this study

Official title: Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Conditions: Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
Being tested: Maestro, iVue

What participants receive

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

MaestroDevice
OCT machines used for diagnostic purposes
iVueDevice
OCT machines used for diagnostic purposes

Study groups in NCT02277119
Study group	Role	What they receive
Normal Eyes	Experimental	Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Receives: Device: Maestro; Device: iVue
Glaucomatous Eyes	Experimental	Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Receives: Device: Maestro; Device: iVue
Eyes with Retinal Diseases	Experimental	Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Receives: Device: Maestro; Device: iVue

What is being measured

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

Optic Disc Measurements (Optic Disc Size)
Reporting of the Optic Disc Size difference between the Maestro and iVue
Measured: 1 Hour
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
RNFL thickness measured
Measured: 1 Hour
Full Retinal Thickness Measurement
Full Retinal Thicknesses Measurement
Measured: 1 Hour
Optic Disc Measurement (Cup Size)
Reporting of the Cup size difference between the Maestro and iVue
Measured: 1 Hour

Timeline

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

Oct 2014Feb 2015

First posted28 Oct 2014 (estimated)
Study startOct 2014
Primary completionJan 2015
Study completionFeb 2015

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 Normal Healthy Subjects With No Known Ocular DiseasesStudies 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: Single blind
Who is masked: Participant
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02277119
Sponsor's protocol ID: Maestro2
Status last verified: Jun 2022
First submitted: 21 Oct 2014
Last updated: 28 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Topcon 3D OCT-1 Maestro Optic Disc and RNFL Study: Agreement and Repeatability Comparison With the iVue
ClinicalTrials.gov ID: NCT02277119
Acronym / sponsor ID: Maestro2
Conditions: Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jan 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 28 Oct 2014 (estimated)
Results: Posted 2 Nov 2016

Clinical summary

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

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Normal Eyes	Experimental	Device: Maestro, Device: iVueSubjects with no known ocular diseases will be scanned with the iVue and Maestro device
Glaucomatous Eyes	Experimental	Device: Maestro, Device: iVueSubjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device
Eyes with Retinal Diseases	Experimental	Device: Maestro, Device: iVueSubjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Subjects 18 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
Subjects presenting at the site with normal eyes (eyes without pathology)
lOPs 21mmHg bilaterally
BCVA 20/40 or better (each eye)

Key exclusion criteria (26 listed)

Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images
HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses> 33% or false positives > 25%, or false negatives > 25%

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
MaestroOCT machines used for diagnostic purposes	Device	Eyes with Retinal Diseases, Glaucomatous Eyes, Normal Eyes
iVueOCT machines used for diagnostic purposes	Device	Eyes with Retinal Diseases, Glaucomatous Eyes, Normal Eyes

Primary outcome

Optic Disc Measurements (Optic Disc Size)
Time frame: 1 Hour
Reporting of the Optic Disc Size difference between the Maestro and iVue
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements
Time frame: 1 Hour
RNFL thickness measured
Full Retinal Thickness Measurement
Time frame: 1 Hour
Full Retinal Thicknesses Measurement
Optic Disc Measurement (Cup Size)
Time frame: 1 Hour
Reporting of the Cup size difference between the Maestro and iVue

Results and safety

Results posted to the registry on 2 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Eyes	58	55
Glaucomatous Eyes	24	20
Eyes With Retinal Diseases	27	19

Primary outcome: Optic Disc Measurements (Optic Disc Size)

Time frame: 1 Hour. Mean (Standard Deviation). Unit: Mircrons squared

Measure	Normal Eyes n = 58	Glaucomatous Eyes n = 24	Eyes With Retinal Diseases n = 27
Value	0.197 (.228)	0.097 (0.216)	0.201 (0.262)

Primary outcome: Retinal Nerve Fiber Layer (RNFL) Thickness Measurements

Time frame: 1 Hour. Mean (Standard Deviation). Unit: Microns

Measure	Normal Eyes n = 58	Glaucomatous Eyes n = 24	Eyes With Retinal Diseases n = 27
Value	4.682 (4.333)	2.526 (6.367)	4.103 (8.789)

Primary outcome: Full Retinal Thickness Measurement

Time frame: 1 Hour. Mean (Standard Deviation). Unit: Microns

Measure	Normal Eyes n = 19	Glaucomatous Eyes n = 0	Eyes With Retinal Diseases n = 18
Value	22.845 (11.482)	–	21.299 (24.524)

Population analysed: Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.

Primary outcome: Optic Disc Measurement (Cup Size)

Time frame: 1 Hour. Mean (Standard Deviation). Unit: Microns cubed

Measure	Normal Eyes n = 58	Glaucomatous Eyes n = 24	Eyes With Retinal Diseases n = 27
Value	0 (0.072)	-0.003 (0.124)	0.016 (0.065)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Eyes	0 of 58 (0%)	0 of 58 (0%)	Not reported
Glaucomatous Eyes	0 of 24 (0%)	0 of 24 (0%)	Not reported
Eyes With Retinal Diseases	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Mike Sinai, PhD study director

Topcon Corporation

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

Questions about this trial

What is this clinical trial studying?

A study testing Maestro and iVue in people with Normal Healthy Subjects With No Known Ocular Diseases and Glaucomatous Eyes, run by Topcon Medical Systems, Inc. at 2 sites 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 17 inclusion and 26 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 Nov 2016). 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?

Optic Disc Measurements (Optic Disc Size) (time frame: 1 Hour). The study lists 4 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 NCT02277119.

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 28 Jun 2022.