Subjects Presenting With Normal EyesNCT02447133
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
An observational study of Subjects Presenting With Normal Eyes, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects Presenting With Normal Eyes
- What is being tested?
- 3D OCT-1 Maestro
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2015
- Phase
- Observational
- 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
Study population: Subjects with no known eye disease
Who may be able to join
- Participants must be at least 18 years of age
- They must be able to complete all testing (all OCT scans)
- They must volunteer to be in the study and sign the consent form
Who cannot join
- Subject with history of ocular disease or ocular pathology
- TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems, Inc.
Oakland, New Jersey, 07436
About this study
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
Read the detailed description
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.
- Conditions
- Subjects Presenting With Normal Eyes
- Being tested
- 3D OCT-1 Maestro
- Keywords
- no known ocular pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D OCT-1 MaestroDevice
OCT Machine used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on 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.
TopQ Cut Off
To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.
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 posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2015
- Study completionMay 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 Subjects Presenting With Normal EyesStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randy Sun, MD, Principal investigator, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447133
- Sponsor's protocol ID
- Topcon 001-2015
- Status last verified
- Jun 2022
- First submitted
- 11 May 2015
- Last updated
- 29 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
- ClinicalTrials.gov ID
- NCT02447133
- Acronym / sponsor ID
- Topcon 001-2015
- Conditions
- Subjects Presenting With Normal Eyes
- Keywords
- no known ocular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 31 Jan 2017
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 validate the TopQ cutoff scores, which have been previously determined.
Detailed description
Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Presenting With Normal Eyes | – | Device: 3D OCT-1 MaestroSubjects with no known ocular diseases will be scanned on the 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 known eye disease
Key inclusion criteria (3 listed)
- Participants must be at least 18 years of age
- They must be able to complete all testing (all OCT scans)
- They must volunteer to be in the study and sign the consent form
Key exclusion criteria (2 listed)
- Subject with history of ocular disease or ocular pathology
- TopQ score from baseline OCT scan (i.e., without any ND filters) is below the cut-off value.
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 Machine used for diagnostic purposes | Device | Subjects Presenting With Normal Eyes |
Primary outcome
TopQ Cut Off
Time frame: 1 hour
To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Randy Sun, MD principal investigator
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 Subjects Presenting With Normal 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 3 inclusion and 2 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 29 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?
Yes. Results are posted in the registry (first posted 31 Jan 2017). 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?
TopQ Cut Off (time frame: 1 hour). 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 29 Jun 2022.