Healthy EyesNCT03022383
TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
An observational study of Healthy Eyes, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Eyes
- What is being tested?
- DRI OCT Triton plus
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Apr 2017
- 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 known eye disease.
Who may be able to join
- Participants must be at least 18 years of age
- Participants must be able to complete all testing (all OCT scans)
- Participants must volunteer to be in the study and sign the consent form
Who cannot join
- Subject with history of ocular disease or ocular pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems Inc.
Oakland, New Jersey, 07436
About this study
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus
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
- Healthy Eyes
- Being tested
- DRI OCT Triton plus
- Keywords
- no known ocular pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRI OCT Triton plusDevice
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 DRI OCT Triton Plus device Receives: Device: DRI OCT Triton plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Variability of Signal to Noise Ratio
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 posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei-Chieh Huang, PhD, Principal investigator, Topcon Medical Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022383
- Sponsor's protocol ID
- Topcon Triton 1222-2016
- Status last verified
- Jun 2022
- First submitted
- 11 Jan 2017
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus
- ClinicalTrials.gov ID
- NCT03022383
- Acronym / sponsor ID
- Topcon Triton 1222-2016
- Conditions
- Healthy Eyes
- Keywords
- no known ocular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Jan 2017 (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.
To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus
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: DRI OCT Triton plusSubjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus 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
- Participants must be able to complete all testing (all OCT scans)
- Participants must volunteer to be in the study and sign the consent form
Key exclusion criteria (1 listed)
- Subject with history of ocular disease or ocular pathology
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 |
|---|---|---|
| DRI OCT Triton plusOCT Machine used for diagnostic purposes | Device | Subjects Presenting With Normal Eyes |
Primary outcome
Measurement Variability of Signal to Noise Ratio
Time frame: 1 hour
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.
- Individual participant dataSharing planned: Undecided
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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.
Wei-Chieh Huang, PhD principal investigator
Topcon Medical Systems, Inc.
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 Healthy 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 1 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?
Measurement Variability of Signal to Noise Ratio (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 8 Jun 2022.