Normal Healthy Subjects With No Known Ocular DiseasesNCT02376868
Maestro Agreement and Precision Study II
An observational study of Normal Healthy Subjects With No Known Ocular Diseases and Glaucomatous Eyes, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell 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?
- 3D OCT-1 Maestro and iVue
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects with no eye disease and subjects with retinal disease or glaucoma.
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)
- lOP <=21 mmHg bilaterally
- BCVA 20/40 or better (each eye)
- Both eyes must be free of eye disease
Show all 22Show fewer
- 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
- BCVA 20/40 or better in the study eye
- Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two 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;
- Glaucoma hemi-field test "outside normal limits."
- Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
- Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
- Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
- Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
- 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<= 21 mmHg 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 previously enrolled in either the Maestro AP study or the Maestro2 study
- 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 (based on manufacturer's recommendation), defined as fixation losses> 20% or false positives> 33%, or false negatives> 33%
- Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two 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;
Show all 25Show fewer
- Glaucoma hemi-field test "outside normal limits."
- Presence of any ocular pathology except for cataract
- Narrow angle
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
- Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
- 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> 20% or false positives> 33%, or false negatives > 33% in the study eye
- Presence of any ocular pathology except glaucoma in the study eye
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
- Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
- 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
- Narrow angle in the study eye
- History of leukemia, dementia or multiple sclerosis
- Concomitant use of hydroxychloroquine and chloroquine
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91716
About this study
Official title: Topcon 3D OCT-1 Maestro Agreement and Precision Study II
Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell 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
- 3D OCT-1 Maestro, iVue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D OCT-1 MaestroDevice
OCT machines used for diagnostic purposes
iVueDevice
OCT machines used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Normal Eyes | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device Receives: Device: 3D OCT-1 Maestro; Device: iVue | |
| Glaucomatous Eyes | Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device Receives: Device: 3D OCT-1 Maestro; Device: iVue | |
| Eyes with Retinal Diseases | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device Receives: Device: 3D OCT-1 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/Cup Size)
Reporting of the Optic Disc Size and Cup Size
Measured: 1 Hour
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours
RNFL thickness measured at different clock hours
Measured: 1 Hour
Full Retinal Thickness Measurements
Full Retinal Thicknesses measured in different quadrants of the scan
Measured: 1 Hour
Ganglion Cell Thickness Measurements
Ganglion Cell Thickness measured in different quadrants of the scan
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Reisman, MS, Study director, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376868
- Sponsor's protocol ID
- MaestroAPII
- Status last verified
- Jun 2022
- First submitted
- 25 Feb 2015
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topcon 3D OCT-1 Maestro Agreement and Precision Study II
- ClinicalTrials.gov ID
- NCT02376868
- Acronym / sponsor ID
- MaestroAPII
- Conditions
- Normal Healthy Subjects With No Known Ocular Diseases, Glaucomatous Eyes, Eyes With Retinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
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, Full Retinal Thickness, and Ganglion Cell Thickness between the Maestro and iVue OCT devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Eyes | – | Device: 3D OCT-1 Maestro, Device: iVueSubjects with no known ocular diseases will be scanned with the iVue and Maestro device |
| Glaucomatous Eyes | – | Device: 3D OCT-1 Maestro, Device: iVueSubjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device |
| Eyes with Retinal Diseases | – | Device: 3D OCT-1 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
- Study population
- Subjects with no eye disease and subjects with retinal disease or glaucoma.
Key inclusion criteria (22 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)
- lOP <=21 mmHg bilaterally
- BCVA 20/40 or better (each eye)
Key exclusion criteria (25 listed)
- Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
- 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 (based on manufacturer's recommendation), defined as fixation losses> 20% or false positives> 33%, or false negatives> 33%
- Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two findings:
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 |
|---|---|---|
| 3D OCT-1 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/Cup Size)
Time frame: 1 Hour
Reporting of the Optic Disc Size and Cup Size
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours
Time frame: 1 Hour
RNFL thickness measured at different clock hours
Full Retinal Thickness Measurements
Time frame: 1 Hour
Full Retinal Thicknesses measured in different quadrants of the scan
Ganglion Cell Thickness Measurements
Time frame: 1 Hour
Ganglion Cell Thickness measured in different quadrants of the scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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.
Charles Reisman, MS study director
Topcon Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Healthy Subjects With No Known Ocular Diseases and Glaucomatous Eyes, run by Topcon Medical Systems, Inc. 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 22 inclusion and 25 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 8 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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/Cup 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?
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 8 Jun 2022.