Retina Condition Followed by Fluorescein Angiography ImagingNCT04701931
OCT Angiography Software Evaluation Study
An observational study of Retina Condition Followed by Fluorescein Angiography Imaging, run by Topcon Corporation at 2 sites in United States.
Trial summary
Comparisons for vascular structure visualization in the retina and choroid. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retina Condition Followed by Fluorescein Angiography Imaging
- What is being tested?
- Maestro2 OCTA, Cirrus HD-OCT 5000 and TRC-50DX
- Type of treatment
- Medical device
- How many people
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jan 2021to 6 Jun 2023
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population with normal eye or eyes with pathology
Pathology Population Inclusion Criteria
- 22 years of age or older on the date of informed consent
- Able to understand the written informed consent and willing to participate by signing the informed consent
- Current diagnosis of one or more of the following pathologies in the study eye in two subgroups:
- Vascular pathologies primarily visualized in Superficial and Deep en face OCTA slabs, including but not limited to Diabetic Retinopathy (DR), Branch Retinal Vein Occlusion (BRVO), Central Retinal Vein Occlusion (CRVO), Central Retinal Arterial Occlusion (CRAO), Macular Telangiectasia (MacTel), Sickle Cell Retinopathy (SCR)
- Vascular pathologies primarily visualized in Outer Retina and Choriocapillaris en face OCTA slabs, including but not limited to Neovascular Age-Related Macular Degeneration ("wet" AMD) and Polypoidal Choroidal Vasculopathy (PCV) Exclusion Criteria
- Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Contraindication to pupil dilation 6. Known allergy or other contradictions to fluorescein and/or to indocyanine green or iodides
Normal Population Inclusion Criteria
- 22 years of age or older on the date of informed consent
- Able to understand the written informed consent and willing to participate by signing the informed consent
- BCVA 20/40 or better in the study eye Exclusion Criteria
- Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Clinically significant findings in the study eye in clinical examination 5. Contraindication to pupil dilation 7. Known allergy or contradictions to fluorescein and/or to indocyanine green or iodides
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southeast Retina Center
Augusta, Georgia, 30909
Orange County Retina Medical Group
Santa Ana, California, 92705
About this study
Official title: Topcon Maestro2 OCT Angiography Software Evaluation Study
Comparisons for vascular structure visualization in the retina and choroid.
Read the detailed description
Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.
- Being tested
- Maestro2 OCTA, Cirrus HD-OCT 5000, TRC-50DX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maestro2 OCTADevice
The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Cirrus HD-OCT 5000Device
The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes
TRC-50DXDevice
The TRC-50DX retinal camera images the fundus used for diagnostic purposes
| Study group | Role | What they receive |
|---|---|---|
| Subjects presenting with Normal Eyes | Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX Receives: Device: Maestro2 OCTA; Device: Cirrus HD-OCT 5000; Device: TRC-50DX | |
| Subjects with retinal pathology present in the eye | Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX Receives: Device: Maestro2 OCTA; Device: Cirrus HD-OCT 5000; Device: TRC-50DX |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCTA image quality
The OCTA image quality comparison between Maestro2 and Cirrus
Measured: Day 1
Visibility of key anatomical vascular features
The OCTA visibility comparison between Maestro2 and Cirrus
Measured: Day 1
Identification of key pathological vascular features
the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start7 Jan 2021
- Primary completion9 Nov 2022
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina Condition Followed by 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayra Tafreshi, Study director, CPAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701931
- Sponsor's protocol ID
- THS-TPCN-2020-003
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topcon Maestro2 OCT Angiography Software Evaluation Study
- ClinicalTrials.gov ID
- NCT04701931
- Acronym / sponsor ID
- THS-TPCN-2020-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Topcon CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 8 Jan 2021 (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.
Comparisons for vascular structure visualization in the retina and choroid.
Detailed description
Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects presenting with Normal Eyes | – | Device: Maestro2 OCTA, Device: Cirrus HD-OCT 5000, Device: TRC-50DXSubjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
| Subjects with retinal pathology present in the eye | – | Device: Maestro2 OCTA, Device: Cirrus HD-OCT 5000, Device: TRC-50DXSubjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population with normal eye or eyes with 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 |
|---|---|---|
| Maestro2 OCTAThe Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes | Device | Subjects presenting with Normal Eyes, Subjects with retinal pathology present in the eye |
| Cirrus HD-OCT 5000The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes | Device | Subjects presenting with Normal Eyes, Subjects with retinal pathology present in the eye |
| TRC-50DXThe TRC-50DX retinal camera images the fundus used for diagnostic purposes | Device | Subjects presenting with Normal Eyes, Subjects with retinal pathology present in the eye |
Primary outcome
OCTA image quality
Time frame: Day 1
The OCTA image quality comparison between Maestro2 and Cirrus
Visibility of key anatomical vascular features
Time frame: Day 1
The OCTA visibility comparison between Maestro2 and Cirrus
Identification of key pathological vascular features
Time frame: Day 1
the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA
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 5 Jul 2023.
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.
Mayra Tafreshi study director
CPAD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retina Condition Followed by Fluorescein Angiography Imaging, run by Topcon Corporation at 2 sites 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?
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 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
OCTA image quality (time frame: Day 1). 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 5 Jul 2023.