Healthy EyesNCT02982174
Evaluation of the Signal to Noise Ratio at Various Retinal Layers
An observational study of Healthy Eyes, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
Compare the signal to noise ratio of each device at various retinal layers. 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?
- 3D OCT-1 Maestro and DRI OCT Triton
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jan 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: 30 subjects willing to participate in this study.
Who may be able to join
- Male or female patients > 18 years old who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date.
- Subjects who agree to participate in the study.
Who cannot join
- History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
- Fixation problems which may prevent obtaining good quality images in either eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems Inc.
Oakland, New Jersey, 07436
About this study
Official title: Evaluation of the Signal to Noise Ratio at Various Retinal Layers in Spectral Domain Optical Coherence Tomography (SD OCT) Compared to Swept Source Optical Coherence Tomography (SS OCT)
Compare the signal to noise ratio of each device at various retinal layers.
Read the detailed description
Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects
- Conditions
- Healthy Eyes
- Being tested
- 3D OCT-1 Maestro, 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.
3D OCT-1 MaestroDevice
Image acquisition of the posterior surface of the eye
DRI OCT TritonDevice
Image acquisition of the posterior surface of the eye
| Study group | Role | What they receive |
|---|---|---|
| Normal Eyes | Subjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton Receives: Device: 3D OCT-1 Maestro; Device: DRI OCT Triton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to noise ratio between SD OCT and SS OCT
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 posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2016
- Study completionJan 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
- 15 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
- NCT02982174
- Sponsor's protocol ID
- Topcon-601-2016
- Status last verified
- Jun 2022
- First submitted
- 29 Nov 2016
- Last updated
- 8 Jun 2022
- 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 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Signal to Noise Ratio at Various Retinal Layers in Spectral Domain Optical Coherence Tomography (SD OCT) Compared to Swept Source Optical Coherence Tomography (SS OCT)
- ClinicalTrials.gov ID
- NCT02982174
- Acronym / sponsor ID
- Topcon-601-2016
- Conditions
- Healthy Eyes
- Keywords
- no known ocular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 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.
Compare the signal to noise ratio of each device at various retinal layers.
Detailed description
Compare the signal to noise ratio of each device (SD OCT and SS OCT) at various retinal layers from the same group of subjects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Eyes | – | Device: 3D OCT-1 Maestro, Device: DRI OCT TritonSubjects with no known ocular diseases will be imaged on the 3D OCT-1 Maestro and DRI OCT Triton |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 subjects willing to participate in this study.
Key inclusion criteria (3 listed)
- Male or female patients > 18 years old who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date.
- Subjects who agree to participate in the study.
Key exclusion criteria (2 listed)
- History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
- Fixation problems which may prevent obtaining good quality images in either eye.
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 MaestroImage acquisition of the posterior surface of the eye | Device | Normal Eyes |
| DRI OCT TritonImage acquisition of the posterior surface of the eye | Device | Normal Eyes |
Primary outcome
Signal to noise ratio between SD OCT and SS OCT
Time frame: 5 minutes
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: 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.
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 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 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?
Signal to noise ratio between SD OCT and SS OCT (time frame: 5 minutes). 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.