Retinal VascularOCTANCT04604002
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
An observational study of Retinal Vascular and Normal Eyes, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular, Normal Eyes
- What is being tested?
- OCT Angiography, Color Fundus Photography and Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 4 Jan 2022
- 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: Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology
Who may be able to join
- All Populations:
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Normal Population:
- 3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
- Pathology Population:
- 3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye
Who cannot join
- All Populations:
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
- Subjects who cannot tolerate the imaging procedures
- Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Read the detailed description
The objectives of this study are:
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
- Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
- Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.
- Conditions
- Retinal Vascular, Normal Eyes
- Being tested
- OCT Angiography, Color Fundus Photography, Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT AngiographyDevice
Also called Optical Coherence Tomography Angiography, OCTA
OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
Color Fundus PhotographyDevice
Also called CFP
Non-contact white light photography
Optical Coherence TomographyDevice
Also called OCT
A non-contact test that uses light waves to take cross-sectional pictures of the retina
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Normal Eyes | OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology Receives: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography | |
| Subjects with Pathology | OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology Receives: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality score
Graded 0-2 (0 = poor, 1 = average, 2 = good)
Measured: through study completion, an average of 1 day
Visibility of OCTA key anatomical vascular structures quality score
Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities
Measured: through study completion, an average of 1 day
Identification of vascular abnormalities on OCTA
Graded Yes, No, or Unable to Grade based on pre-specified abnormalities
Measured: through study completion, an average of 1 day
Adverse Events
All AEs
Measured: through study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start15 Oct 2020
- Primary completion4 Jan 2022
- Study completion4 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal VascularStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Marcus, MD, Principal investigator, Southeast Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604002
- Sponsor's protocol ID
- S-2020-5
- Acronym
- OCTA
- Status last verified
- Feb 2024
- First submitted
- 20 Oct 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
- ClinicalTrials.gov ID
- NCT04604002
- Acronym / sponsor ID
- OCTA / S-2020-5
- Conditions
- Retinal Vascular, Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 27 Oct 2020 (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.
Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Detailed description
The objectives of this study are:
1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.
- Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.
- Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Normal Eyes | – | Device: OCT Angiography, Device: Color Fundus Photography, Device: Optical Coherence TomographyOCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology |
| Subjects with Pathology | – | Device: OCT Angiography, Device: Color Fundus Photography, Device: Optical Coherence TomographyOCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Healthy Eyes and Adults with Eyes with retinal vascular pathology
Key inclusion criteria (7 listed)
- All Populations:
- Normal Population:
- 3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
- Pathology Population:
- 3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye
Key exclusion criteria (5 listed)
- All Populations:
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 |
|---|---|---|
| OCT AngiographyAlso: Optical Coherence Tomography Angiography, OCTAOCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes. | Device | Subjects with Normal Eyes, Subjects with Pathology |
| Color Fundus PhotographyAlso: CFPNon-contact white light photography | Device | Subjects with Normal Eyes, Subjects with Pathology |
| Optical Coherence TomographyAlso: OCTA non-contact test that uses light waves to take cross-sectional pictures of the retina | Device | Subjects with Normal Eyes, Subjects with Pathology |
Primary outcome
Image quality score
Time frame: through study completion, an average of 1 day
Graded 0-2 (0 = poor, 1 = average, 2 = good)
Visibility of OCTA key anatomical vascular structures quality score
Time frame: through study completion, an average of 1 day
Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities
Identification of vascular abnormalities on OCTA
Time frame: through study completion, an average of 1 day
Graded Yes, No, or Unable to Grade based on pre-specified abnormalities
Adverse Events
Time frame: through study completion, an average of 1 day
All AEs
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 28 Feb 2024.
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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.
Dennis Marcus, MD principal investigator
Southeast Retina Center
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 Retinal Vascular and Normal Eyes, run by Heidelberg Engineering GmbH 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 7 inclusion and 5 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 28 Feb 2024. 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?
Image quality score (time frame: through study completion, an average of 1 day). The study lists 4 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 28 Feb 2024.