Healthy EyesNCT02991027
OCT Image Quality Performance Evaluation
A study testing DRI OCT Triton in people with Healthy Eyes, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2016to 2 Jul 2017
- Phase
- Interventional
- 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
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
- Subjects unable to complete all OCT imaging modes
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems Inc.
Oakland, New Jersey, 07436
About this study
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.
Read the detailed description
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.
- Conditions
- Healthy Eyes
- Being tested
- DRI OCT Triton
- 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 TritonDevice
DRI OCT Triton using micro-electro-mechanical short cavity tunable laser
DRI OCT TritonDevice
DRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser
| Study group | Role | What they receive |
|---|---|---|
| Subjects Presenting With Normal Eyes | Experimental | Subjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton Receives: Device: DRI OCT Triton |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT image quality
Measured: 5 minutes
OCT angiography image quality
Measured: 5 minutes
Secondary outcomes (1)
Full Retinal Thickness
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start14 Dec 2016
- Primary completion12 Jun 2017
- Study completion2 Jul 2017
Why it stopped: No subjects needed for enrollment anymore
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhenguo Wang, PhD, Principal investigator, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991027
- Sponsor's protocol ID
- Topcon Tabil-801-2016
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2016
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Image Quality Performance Evaluation
- ClinicalTrials.gov ID
- NCT02991027
- Acronym / sponsor ID
- Topcon Tabil-801-2016
- Conditions
- Healthy Eyes
- Keywords
- no known ocular pathology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects needed for enrollment anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2016 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 2 Jul 2017 (actual)
- First posted
- 13 Dec 2016 (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 evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources.
Detailed description
To evaluate the image qualities and segmentation performance of Topcon's DRI OCT Triton devices using two light sources with equivalent specifications: the micro-electro-mechanical short cavity tunable laser and the micro-electro-mechanical tunable vertical cavity surface emitting laser.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects Presenting With Normal Eyes | Experimental | Device: DRI OCT TritonSubjects with no known ocular diseases will be imaged using 2 different light sources using the DRI Triton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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
- Subjects unable to complete all OCT imaging modes
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 TritonDRI OCT Triton using micro-electro-mechanical short cavity tunable laser | Device | Subjects Presenting With Normal Eyes |
| DRI OCT TritonDRI OCT Triton using micro-electro-mechanical tunable vertical cavity surface emitting laser | Device | Subjects Presenting With Normal Eyes |
Primary outcome
OCT image quality
Time frame: 5 minutes
OCT angiography image quality
Time frame: 5 minutes
1 secondary outcome
Full Retinal Thickness
Time frame: 5 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Zhenguo Wang, PhD 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?
A study testing DRI OCT Triton in people with 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 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: withdrawn, as of the sponsor's last update on 16 Dec 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
OCT image quality (time frame: 5 minutes). The study lists 2 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 16 Dec 2021.