Retinal Artery OcclusionRAO-OCTANCT03357146
Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
An observational study of Retinal Artery Occlusion, run by Semmelweis University at 1 site in Hungary.
Trial summary
Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion with non-invasive, non-contact optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Artery Occlusion
- What is being tested?
- Optical coherence tomography angiography
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteHungary
- Study dates
- 9 Jan 2017to 30 Aug 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: White caucasias
Who may be able to join
- central or branch retinal artery occlusion
- at least 6 months of onset
- signed informed consent
Who cannot join
- known epilepsy
- incapacity
- presence of optical media opacities that would disturb the imaging
- presence of other retinal diseases that would disturb the evaluation of images
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Ophthalmology
Budapest, 1085
About this study
Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion with non-invasive, non-contact optical coherence tomography angiography.
Read the detailed description
Occlusion of the retinal arteries is an emergency which causes sudden, painless unilateral vision loss. Loss of blood flow causes ischemic damage to the retina. The extent of damage depends on the area affected.
Following the acute phase of the disease re-canalization occurs and lesser blood flow can be detected usually without functional recovery.
Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion.
Standard procedures to examine this disease include retinoscopy following pupil dilation, fluorescein angiography and more recently, optical coherence tomography (OCT).
The latest direction in OCT development was OCT angiography (OCTA) which is a software upgrade that allows detection of blood flow based on motion contrast. Similar to previous OCT machines OCTA is also non-invasive and non-contact and does not require any intravenous agents.
OCT machines are approved in the EU and the US and are not experimental devices.
The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex 5000 that operates with spectral-domain technology.
- Conditions
- Retinal Artery Occlusion
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDevice
OCTA scans per built-in device protocol
| Study group | Role | What they receive |
|---|---|---|
| CRA | Patients with chronic retinal artery occlusion Receives: Device: Optical coherence tomography angiography | |
| Control | Healthy Receives: Device: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary density in relation to healthy subjects
Measured: Through study completion, 1 year
Secondary outcomes (1)
Correlation of capillary density and retinal thickness
Measured: Through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start9 Jan 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Retinal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Schneider MD, PhD, Semmelweis University
- Investigators
- Miklos Schneider, Principal investigator, Semmelweis University, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357146
- Sponsor's protocol ID
- RAO-OCTA-1253
- Acronym
- RAO-OCTA
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2017
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.
PubMed 26457398Chalam KV, Sambhav K. Optical Coherence Tomography Angiography in Retinal Diseases. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):84-92. doi: 10.4103/2008-322X.180709.
PubMed 27195091Jia Y, Bailey ST, Hwang TS, McClintic SM, Gao SS, Pennesi ME, Flaxel CJ, Lauer AK, Wilson DJ, Hornegger J, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of vascular abnormalities in the living human eye. Proc Natl Acad Sci U S A. 2015 May 5;112(18):E2395-402. doi: 10.1073/pnas.1500185112. Epub 2015 Apr 20.
PubMed 25897021Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.
PubMed 26469536Savastano MC, Lumbroso B, Rispoli M. IN VIVO CHARACTERIZATION OF RETINAL VASCULARIZATION MORPHOLOGY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2196-203. doi: 10.1097/IAE.0000000000000635.
PubMed 25932558Spaide RF. VOLUME-RENDERED ANGIOGRAPHIC AND STRUCTURAL OPTICAL COHERENCE TOMOGRAPHY. Retina. 2015 Nov;35(11):2181-7. doi: 10.1097/IAE.0000000000000764.
PubMed 26428608Yu S, Lu J, Cao D, Liu R, Liu B, Li T, Luo Y, Lu L. The role of optical coherence tomography angiography in fundus vascular abnormalities. BMC Ophthalmol. 2016 Jul 13;16:107. doi: 10.1186/s12886-016-0277-2.
PubMed 27412442
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
- ClinicalTrials.gov ID
- NCT03357146
- Acronym / sponsor ID
- RAO-OCTA / RAO-OCTA-1253
- Conditions
- Retinal Artery Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 29 Nov 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.
Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion with non-invasive, non-contact optical coherence tomography angiography.
Detailed description
Occlusion of the retinal arteries is an emergency which causes sudden, painless unilateral vision loss. Loss of blood flow causes ischemic damage to the retina. The extent of damage depends on the area affected.
Following the acute phase of the disease re-canalization occurs and lesser blood flow can be detected usually without functional recovery.
Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion.
Standard procedures to examine this disease include retinoscopy following pupil dilation, fluorescein angiography and more recently, optical coherence tomography (OCT).
The latest direction in OCT development was OCT angiography (OCTA) which is a software upgrade that allows detection of blood flow based on motion contrast. Similar to previous OCT machines OCTA is also non-invasive and non-contact and does not require any intravenous agents.
OCT machines are approved in the EU and the US and are not experimental devices.
The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex 5000 that operates with spectral-domain technology.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRA | – | Device: Optical coherence tomography angiographyPatients with chronic retinal artery occlusion |
| Control | – | Device: Optical coherence tomography angiographyHealthy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- White caucasias
Key inclusion criteria (3 listed)
- central or branch retinal artery occlusion
- at least 6 months of onset
- signed informed consent
Key exclusion criteria (4 listed)
- known epilepsy
- incapacity
- presence of optical media opacities that would disturb the imaging
- presence of other retinal diseases that would disturb the evaluation of images
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 angiographyOCTA scans per built-in device protocol | Device | CRA, Control |
Primary outcome
Capillary density in relation to healthy subjects
Time frame: Through study completion, 1 year
1 secondary outcome
Correlation of capillary density and retinal thickness
Time frame: Through study completion, 1 year
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 6 Oct 2021.
- Background: PubMed 26457398Bonini Filho MA, Adhi M, de Carlo TE, Ferrara D, Baumal CR, Witkin AJ, Reichel E, Kuehlewein L, Sadda SR, Sarraf D, Duker JS, Waheed NK. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY IN RETINAL ARTERY OCCLUSION. Retina. 2015 Nov;35(11):2339-46. doi: 10.1097/IAE.0000000000000850.
- Background: PubMed 27195091Chalam KV, Sambhav K. Optical Coherence Tomography Angiography in Retinal Diseases. J Ophthalmic Vis Res. 2016 Jan-Mar;11(1):84-92. doi: 10.4103/2008-322X.180709.
- Background: PubMed 25897021Jia Y, Bailey ST, Hwang TS, McClintic SM, Gao SS, Pennesi ME, Flaxel CJ, Lauer AK, Wilson DJ, Hornegger J, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of vascular abnormalities in the living human eye. Proc Natl Acad Sci U S A. 2015 May 5;112(18):E2395-402. doi: 10.1073/pnas.1500185112. Epub 2015 Apr 20.
- Background: PubMed 26469536Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.
- Background: PubMed 25932558Savastano MC, Lumbroso B, Rispoli M. IN VIVO CHARACTERIZATION OF RETINAL VASCULARIZATION MORPHOLOGY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2196-203. doi: 10.1097/IAE.0000000000000635.
- Background: PubMed 26428608Spaide RF. VOLUME-RENDERED ANGIOGRAPHIC AND STRUCTURAL OPTICAL COHERENCE TOMOGRAPHY. Retina. 2015 Nov;35(11):2181-7. doi: 10.1097/IAE.0000000000000764.
- Background: PubMed 27412442Yu S, Lu J, Cao D, Liu R, Liu B, Li T, Luo Y, Lu L. The role of optical coherence tomography angiography in fundus vascular abnormalities. BMC Ophthalmol. 2016 Jul 13;16:107. doi: 10.1186/s12886-016-0277-2.
- 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.
Miklos Schneider principal investigator
Semmelweis University, Department of 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 Artery Occlusion, run by Semmelweis University at 1 site in Hungary.
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 3 inclusion and 4 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 6 Oct 2021. 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 Hungary. 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?
Capillary density in relation to healthy subjects (time frame: Through study completion, 1 year). 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 NCT03357146, which also lists 7 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 6 Oct 2021.