Retinal DiseaseNCT02811536
Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
An observational study of Retinal Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- optical coherence tomography angiography
- Type of treatment
- Medical device
- How many people
- 440 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Feb 2017to 25 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with a history of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular macroaneurysma, and diabetic macular edema and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
Who may be able to join
- Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older
Who cannot join
- Patients not willing or able to sign informed consent Patients younger than 18 years Patients with epilepsy Patients having had photodynamic therapy within the last 48 hours prior to imaging with OCTA
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital Bern, Department of Ophthalmology
Bern, 3010
About this study
Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases
Read the detailed description
Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.
- Conditions
- Retinal Disease
- Being tested
- optical coherence tomography angiography
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography angiographyDevice
Imaging with optical coherence tomography angiography
| Study group | Role | What they receive |
|---|---|---|
| Diabetic retinopathy | Patients with various degrees of diabetic retinopathy Receives: Device: optical coherence tomography angiography | |
| Retinal detachment | Patients with a history of retinal detachment Receives: Device: optical coherence tomography angiography | |
| Retinal vein occlusion | Patients with a history of retinal vein occlusion Receives: Device: optical coherence tomography angiography | |
| Arterial hypertension | Patients with a history of arterial hypertension Receives: Device: optical coherence tomography angiography | |
| Carotid artery occlusion | Patients with a history of carotid artery occlusion Receives: Device: optical coherence tomography angiography | |
| Age related macular degeneration | Patients with a history of Age related macular degeneration Receives: Device: optical coherence tomography angiography | |
| Macroaneurysms | Patients with a history of retinal macroaneurysms Receives: Device: optical coherence tomography angiography | |
| Central serous chorioretinopathy | Patients with a history of central serous chorioretinopathy Receives: Device: optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the sensitivity and specificity of OCTA
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
Measured: 2 years
Secondary outcomes (3)
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
Measured: 2 years
OCTA and Fundus color photographs
Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA
Measured: 2 years
Subgroup analysis
Subgroup analysis will be performed with patients suffering from diabetic retinopathy, artery occlusion, carotid stenosis, retinal detachment, vein occlusion, age related macular degeneration, retinal changes from arterial hypertension, retinal macroaneurysms and uveitis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start13 Feb 2017
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Zinkernagel, Prof.MD PhD, Study chair, Inselspital, University Clinic for Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811536
- Sponsor's protocol ID
- OCTA Bern
- Status last verified
- Nov 2022
- First submitted
- 20 Jun 2016
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tian M, Zeng G, Zinkernagel M, Tappeiner C, Wolf S, Munk MR. Assessment of choriocapillaris and choroidal vascular changes in posterior uveitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2024 Feb 21;108(3):386-390. doi: 10.1136/bjo-2022-322209.
PubMed 36627172Tian M, Tappeiner C, Zinkernagel MS, Huf W, Wolf S, Munk MR. Evaluation of vascular changes in intermediate uveitis and retinal vasculitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2019 Sep;103(9):1289-1295. doi: 10.1136/bjophthalmol-2018-313078. Epub 2018 Dec 11.
PubMed 30538102
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
- ClinicalTrials.gov ID
- NCT02811536
- Acronym / sponsor ID
- OCTA Bern
- Conditions
- Retinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 23 Jun 2016 (estimated)
- 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.
Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases
Detailed description
Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Diabetic retinopathy | – | Device: optical coherence tomography angiographyPatients with various degrees of diabetic retinopathy |
| Retinal detachment | – | Device: optical coherence tomography angiographyPatients with a history of retinal detachment |
| Retinal vein occlusion | – | Device: optical coherence tomography angiographyPatients with a history of retinal vein occlusion |
| Arterial hypertension | – | Device: optical coherence tomography angiographyPatients with a history of arterial hypertension |
| Carotid artery occlusion | – | Device: optical coherence tomography angiographyPatients with a history of carotid artery occlusion |
| Age related macular degeneration | – | Device: optical coherence tomography angiographyPatients with a history of Age related macular degeneration |
| Macroaneurysms | – | Device: optical coherence tomography angiographyPatients with a history of retinal macroaneurysms |
| Central serous chorioretinopathy | – | Device: optical coherence tomography angiographyPatients with a history of central serous chorioretinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a history of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular macroaneurysma, and diabetic macular edema and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
Key inclusion criteria (1 listed)
- Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older
Key exclusion criteria (1 listed)
- Patients not willing or able to sign informed consent Patients younger than 18 years Patients with epilepsy Patients having had photodynamic therapy within the last 48 hours prior to imaging with OCTA
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 |
|---|---|---|
| optical coherence tomography angiographyImaging with optical coherence tomography angiography | Device | Age related macular degeneration, Arterial hypertension, Carotid artery occlusion, Central serous chorioretinopathy, Diabetic retinopathy, Macroaneurysms, Retinal detachment, Retinal vein occlusion |
Primary outcome
Evaluation of the sensitivity and specificity of OCTA
Time frame: 2 years
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
3 secondary outcomes
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA
Time frame: 2 years
OCTA and Fundus color photographs
Time frame: 2 years
Subgroup analysis
Time frame: 2 years
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 29 Nov 2022.
- Derived from this study: PubMed 36627172Tian M, Zeng G, Zinkernagel M, Tappeiner C, Wolf S, Munk MR. Assessment of choriocapillaris and choroidal vascular changes in posterior uveitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2024 Feb 21;108(3):386-390. doi: 10.1136/bjo-2022-322209.
- Derived from this study: PubMed 30538102Tian M, Tappeiner C, Zinkernagel MS, Huf W, Wolf S, Munk MR. Evaluation of vascular changes in intermediate uveitis and retinal vasculitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2019 Sep;103(9):1289-1295. doi: 10.1136/bjophthalmol-2018-313078. Epub 2018 Dec 11.
- 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.
Martin Zinkernagel, Prof.MD PhD study chair
Inselspital, University Clinic for Ophthalmology
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 Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 1 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 29 Nov 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 Switzerland. 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?
Evaluation of the sensitivity and specificity of OCTA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811536, which also lists 2 linked publications.
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 29 Nov 2022.