Medical Need for Fluorescein Angiography ImagingNCT03107104
Triton Fundus Autofluorescence and Fluorescein Angiography
An observational study of Medical Need for Fluorescein Angiography Imaging, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
Compare the image quality of the fundus autofluorescence and fluorescein angiography Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Need for Fluorescein Angiography Imaging
- What is being tested?
- Topcon DRI OCT Triton (plus) and TRC-50DX retinal camera
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2017to 30 Sep 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 medical need for FA imaging
Who may be able to join
- Subjects must be at least 18 years of age
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects who consent to, via clinic's standard FA consent form, and will undergo dye injection for FA imaging at the clinic visit based on medical need
Who cannot join
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable fundus images
- Patients with ocular motility dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreous Retina Macula Consultants of New York
New York, New York, 10022
About this study
Official title: Topcon DRI OCT Triton (Plus) Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study
Compare the image quality of the fundus autofluorescence and fluorescein angiography
Read the detailed description
The objectives of this study are to:
- Compare the image quality of the fundus autofluorescence (FAF) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
- Compare the image quality of the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
- Being tested
- Topcon DRI OCT Triton (plus), TRC-50DX retinal camera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topcon DRI OCT Triton (plus)Device
The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes
TRC-50DX retinal cameraDevice
The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Medical need for FA imaging | Subjects deemed to have a medical need for FA imaging will be imaged on the Topcon DRI OCT Triton (plus) and TRC-50DX retinal camera Receives: Device: Topcon DRI OCT Triton (plus); Device: TRC-50DX retinal camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus autofluorescence image quality
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
Measured: 1 Minute
Fluorescein angiography image quality at 120 seconds to 300 seconds after dye injection
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
Measured: 120 seconds to 300 seconds
Fluorescein angiography image quality at greater than 300 seconds after dye injection
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
Measured: greater than 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start30 Mar 2017
- Primary completion30 Aug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Need for Fluorescein Angiography ImagingStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Riesman, MS, Study chair, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107104
- Sponsor's protocol ID
- Triton FA FAF
- Status last verified
- Jun 2022
- First submitted
- 30 Mar 2017
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Topcon DRI OCT Triton (Plus) Fundus Autofluorescence and Fluorescein Angiography Image Quality Evaluation Study
- ClinicalTrials.gov ID
- NCT03107104
- Acronym / sponsor ID
- Triton FA FAF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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 image quality of the fundus autofluorescence and fluorescein angiography
Detailed description
The objectives of this study are to:
- Compare the image quality of the fundus autofluorescence (FAF) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
- Compare the image quality of the fluorescein angiography (FA) photographs between DRI OCT Triton (plus) and TRC-50DX retinal camera.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical need for FA imaging | – | Device: Topcon DRI OCT Triton (plus), Device: TRC-50DX retinal cameraSubjects deemed to have a medical need for FA imaging will be imaged on the Topcon DRI OCT Triton (plus) and TRC-50DX retinal camera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with medical need for FA imaging
Key inclusion criteria (3 listed)
- Subjects must be at least 18 years of age
- Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- Subjects who consent to, via clinic's standard FA consent form, and will undergo dye injection for FA imaging at the clinic visit based on medical need
Key exclusion criteria (3 listed)
- Subjects unable to tolerate ophthalmic imaging
- Subjects with ocular media not sufficiently clear to obtain acceptable fundus images
- Patients with ocular motility dysfunction
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 DRI OCT Triton (plus)The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes | Device | Medical need for FA imaging |
| TRC-50DX retinal cameraThe TRC-50DX retinal camera is a fundus camera used for diagnostic purposes | Device | Medical need for FA imaging |
Primary outcome
Fundus autofluorescence image quality
Time frame: 1 Minute
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
Fluorescein angiography image quality at 120 seconds to 300 seconds after dye injection
Time frame: 120 seconds to 300 seconds
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
Fluorescein angiography image quality at greater than 300 seconds after dye injection
Time frame: greater than 300 seconds
Comparison of DRI OCT Triton (plus) and TRC-50DX photographs
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
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.
Charles Riesman, MS study chair
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 Medical Need for Fluorescein Angiography Imaging, 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 3 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 autofluorescence image quality (time frame: 1 Minute). The study lists 3 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 8 Jun 2022.