HealthyNCT02447120
Topcon 3D OCT-1 Maestro Reference Database Study II
An observational study of Healthy, run by Topcon Medical Systems, Inc. at 7 sites in United States.
Trial summary
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3D OCT-1 Maestro
- Type of treatment
- Medical device
- How many people
- 504 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2015to Oct 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 without eye disease
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
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 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;
Show all 11Show 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UAB School of Optometry
Birmingham, Alabama, 35233
Illinois College of Optometry
Chicago, Illinois, 60616
Southern California College of Optometry
Fullerton, California, 92831
New York VA
Jamaica, New York, 11425
Valley Eyecare Center
Livermore, California, 94550
SUNY College of Optometry
New York, New York, 10036
Western University of Health Sciences
Pomona, California, 91716
About this study
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.
Read the detailed description
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.
- Conditions
- Healthy
- Being tested
- 3D OCT-1 Maestro
- Keywords
- Volunteers with Healthy Eyes
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
| Study group | Role | What they receive |
|---|---|---|
| Normal Eyes | Subjects with no known ocular diseases will be scanned with the Maestro device Receives: Device: 3D OCT-1 Maestro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Thickness
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 504 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 chair, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447120
- Sponsor's protocol ID
- Maestro_NDB_II
- Status last verified
- Jun 2022
- First submitted
- 12 May 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 Reference Database Study II
- ClinicalTrials.gov ID
- NCT02447120
- Acronym / sponsor ID
- Maestro_NDB_II
- Conditions
- Healthy
- Keywords
- Volunteers with Healthy Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 May 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.
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.
Detailed description
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Eyes | – | Device: 3D OCT-1 MaestroSubjects with no known ocular diseases will be scanned with the Maestro device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects without eye disease
Key inclusion criteria (6 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 (11 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 based on 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 | Normal Eyes |
Primary outcome
Retinal Thickness
Time frame: 1 minute
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.
Related trials for Healthy
Active, not recruitingPhase 1/2
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
Healthy Volunteer, Hypersensitivity Reactions
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
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 chair
Topcon Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Topcon Medical Systems, Inc. at 7 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 6 inclusion and 11 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 7 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?
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?
Retinal Thickness (time frame: 1 minute). 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.