Retinal VascularNCT03530449
Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
An observational study of Retinal Vascular and Normal Eyes, run by Heidelberg Engineering GmbH at 1 site in United States.
Trial summary
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS 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
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to 15 Sep 2018
- 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: Pathology Population: Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal vascular conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included. Normal Population: In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.
Who may be able to join
- All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Subjects with Normal Eyes:
- Corrected visual acuity ≥ 20/40 in each eye
- Subjects with Pathology:
- Subjects with vascular retinal conditions in at least one eye
- Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.
Who cannot join
- All Subjects:
- 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 with contraindication to pupillary dilation in the study eye
- Subjects with Normal Eyes:
- Subjects with uncontrolled systemic conditions, or ocular disease, as determined by the Investigator, during the eye exam and CFP
- History of ocular surgical intervention (except for refractive or cataract surgery) in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York College of Optometry (SUNY)
New York, New York, 10036
About this study
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
Read the detailed description
The objectives of this study are to:
- Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality
- Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module
- 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 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 Structural OCT, OCT
Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Normal Eyes | Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology Receives: Device: OCT Angiography; Device: Color Fundus Photography; Device: Optical Coherence Tomography | |
| Subjects with Retinal Vascular Pathology | Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic 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.
OCTA image quality
Image quality grading results of study selected images
Measured: day 1
Visualization of key anatomical vascular structures on OCTA
Grading of visibility of key anatomical vascular structures of study selected images
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 posted21 May 2018
- Study start30 Apr 2018
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Why it stopped: Management decision; not patient safety related
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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell W Dul, OD, Principal investigator, State University of New York College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530449
- Sponsor's protocol ID
- S-2018-1
- Status last verified
- Feb 2019
- First submitted
- 8 May 2018
- Last updated
- 28 Feb 2019
- 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 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
- ClinicalTrials.gov ID
- NCT03530449
- Acronym / sponsor ID
- S-2018-1
- Conditions
- Retinal Vascular, Normal Eyes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Management decision; not patient safety related
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 21 May 2018 (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.
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
Detailed description
The objectives of this study are to:
- Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality
- Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module
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 TomographyColor Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology |
| Subjects with Retinal Vascular Pathology | – | Device: OCT Angiography, Device: Color Fundus Photography, Device: Optical Coherence TomographyColor Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pathology Population: Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal vascular conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included. Normal Population: In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.
Key inclusion criteria (7 listed)
- All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Corrected visual acuity ≥ 20/40 in each eye
- Subjects with vascular retinal conditions in at least one eye
- Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.
Key exclusion criteria (8 listed)
- All Subjects:
- 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 with contraindication to pupillary dilation in the study 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 |
|---|---|---|
| OCT AngiographyAlso: 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 Retinal Vascular Pathology |
| Color Fundus PhotographyAlso: CFPNon-contact white light photography | Device | Subjects with Normal Eyes, Subjects with Retinal Vascular Pathology |
| Optical Coherence TomographyAlso: Structural OCT, OCTTwo and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases. | Device | Subjects with Normal Eyes, Subjects with Retinal Vascular Pathology |
Primary outcome
OCTA image quality
Time frame: day 1
Image quality grading results of study selected images
Visualization of key anatomical vascular structures on OCTA
Time frame: day 1
Grading of visibility of key anatomical vascular structures of study selected images
Results and safety
The study was stopped early (reason given: Management decision; not patient safety related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
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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.
Mitchell W Dul, OD principal investigator
State University of New York College of Optometry
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 8 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: stopped early, as of the sponsor's last update on 28 Feb 2019. 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 was stopped early (reason given: Management decision; not patient safety related). Results are not available in the source record.
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 2 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 2019.