Normal Healthy Subjects With no Known Ocular DiseasesNCT02293174
Retinal Fundus Camera Evaluation
An observational study of Normal Healthy Subjects With no Known Ocular Diseases, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Subjects With no Known Ocular Diseases
- What is being tested?
- Topcon TRC-NW400, TRC-NW8 and TRC-NW400
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jan 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: Normal subjects will be recruited from Topcon Medical Systems.
Who may be able to join
- Subjects with no known ocular diseases
Who cannot join
- Subjects with known ocular diseases
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: TRC-NW400 Retinal Fundus Camera Image Evaluation and Instrument Comparison Protocol
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.
Read the detailed description
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. While also comparing the images to other manufacturer's retinal cameras
- Being tested
- Topcon TRC-NW400, TRC-NW8, TRC-NW400, Canon-CR2, Zeiss Visucam PRO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon TRC-NW400Device
Retinal Fundus Camera
TRC-NW8Device
Retinal Fundus Camera
TRC-NW400Device
Retinal Fundus Camera
Canon-CR2Device
Retinal Fundus Camera
Zeiss Visucam PRODevice
Retinal Fundus Camera
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Eyes | Willing and able subjects with normal and healthy eyes Receives: Device: Topcon TRC-NW400; Device: TRC-NW8; Device: TRC-NW400; Device: Canon-CR2; Device: Zeiss Visucam PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus Image Grading
Determining the best display to reflect the real color of the retina
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 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy Subjects With no Known Ocular DiseasesStudies 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
- Danny Leung, Principal investigator, Clinical Trial Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293174
- Sponsor's protocol ID
- TOPCON-003-2014
- Status last verified
- Jun 2022
- First submitted
- 11 Nov 2014
- 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
- TRC-NW400 Retinal Fundus Camera Image Evaluation and Instrument Comparison Protocol
- ClinicalTrials.gov ID
- NCT02293174
- Acronym / sponsor ID
- TOPCON-003-2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 18 Nov 2014 (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.
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera.
Detailed description
Establish a normal baseline setting configuration for image capture using the Topcon TRC-NW400 non-mydriatic retinal camera. While also comparing the images to other manufacturer's retinal cameras
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Eyes | – | Device: Topcon TRC-NW400, Device: TRC-NW8, Device: TRC-NW400, Device: Canon-CR2, Device: Zeiss Visucam PROWilling and able subjects with normal and healthy eyes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subjects will be recruited from Topcon Medical Systems.
Key inclusion criteria (1 listed)
- Subjects with no known ocular diseases
Key exclusion criteria (1 listed)
- Subjects with known ocular diseases
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 |
|---|---|---|
| Topcon TRC-NW400Retinal Fundus Camera | Device | Normal Healthy Eyes |
| TRC-NW8Retinal Fundus Camera | Device | Normal Healthy Eyes |
| TRC-NW400Retinal Fundus Camera | Device | Normal Healthy Eyes |
| Canon-CR2Retinal Fundus Camera | Device | Normal Healthy Eyes |
| Zeiss Visucam PRORetinal Fundus Camera | Device | Normal Healthy Eyes |
Primary outcome
Fundus Image Grading
Time frame: 1 Hour
Determining the best display to reflect the real color of the retina
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.
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.
Danny Leung principal investigator
Clinical Trial Manager
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 Normal Healthy Subjects With no Known Ocular Diseases, 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 1 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?
Fundus Image Grading (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.