Retinal VascularNCT03279939
Evaluation of 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
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA. 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 Fluorescein Angiography
- Type of treatment
- Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2017to 12 Jan 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: Subjects with Normal Eyes: * Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator * Corrected visual acuity ≥ 20/40 in each eye * No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye Subjects with Pathology: * Subjects with retinal conditions in at least one eye. * Subjects included can have a range of retinal vascular pathologies 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 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:
- Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
- Corrected visual acuity ≥ 20/40 in each eye
Show all 10Show fewer
- No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye
- Subjects with Pathology:
- Subjects with retinal conditions in at least one eye.
- Subjects included can have a range of retinal vascular pathologies 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
- 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 known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
- Subjects with contraindication to pupillary dilation in study eye
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
Read the detailed description
The objectives of this study are:
- To compare the OCTA image quality between the SPECTRALIS and the predicate.
- To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.
- Conditions
- Retinal Vascular, Normal Eyes
- Being tested
- OCT Angiography, Color Fundus Photography, Fluorescein Angiography, Indocyaine Green Angiography
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.
Fluorescein AngiographyDevice
Also called FA
An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
Indocyaine Green AngiographyDevice
Also called ICGA
An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Normal Eyes | OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology. Receives: Device: OCT Angiography; Device: Color Fundus Photography; Device: Fluorescein Angiography | |
| Subjects with Pathology | OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green Angiography as per protocol in subjects with retinal vascular pathology. Receives: Device: OCT Angiography; Device: Color Fundus Photography; Device: Fluorescein Angiography; Device: Indocyaine Green Angiography |
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
Clinically relevant findings on OCTA
Clinically relevant grading results 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 posted12 Sep 2017
- Study start23 Aug 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Brown, MD, Principal investigator, Retina Consultants Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279939
- Sponsor's protocol ID
- S-2017-1
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2017
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
- ClinicalTrials.gov ID
- NCT03279939
- Acronym / sponsor ID
- S-2017-1
- Conditions
- Retinal Vascular, Normal Eyes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 12 Sep 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.
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
Detailed description
The objectives of this study are:
- To compare the OCTA image quality between the SPECTRALIS and the predicate.
- To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.
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: Fluorescein AngiographyOCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology. |
| Subjects with Pathology | – | Device: OCT Angiography, Device: Color Fundus Photography, Device: Fluorescein Angiography, Device: Indocyaine Green AngiographyOCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green 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
- Subjects with Normal Eyes: * Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator * Corrected visual acuity ≥ 20/40 in each eye * No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye Subjects with Pathology: * Subjects with retinal conditions in at least one eye. * Subjects included can have a range of retinal vascular pathologies 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 inclusion criteria (10 listed)
- Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
- Age ≥ 22
- Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator
- Corrected visual acuity ≥ 20/40 in each eye
- No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye
Key exclusion criteria (5 listed)
- 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 known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation
- Subjects with contraindication to pupillary dilation in 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 Pathology |
| Color Fundus PhotographyAlso: CFPNon-contact white light photography. | Device | Subjects with Normal Eyes, Subjects with Pathology |
| Fluorescein AngiographyAlso: FAAn imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images. | Device | Subjects with Normal Eyes, Subjects with Pathology |
| Indocyaine Green AngiographyAlso: ICGAAn imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images. | Device | Subjects with Pathology |
Primary outcome
OCTA image quality
Time frame: day 1
Image quality grading results of study selected images
Clinically relevant findings on OCTA
Time frame: day 1
Clinically relevant grading results of study selected images
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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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.
David Brown, MD principal investigator
Retina Consultants Houston
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 10 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 15 Sep 2025. 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?
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 15 Sep 2025.