Retinal IschemiaNCT03061526
Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion
An observational study of Retinal Ischemia, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. Intracellular edema may develop and decrease transparency of those layers, showing retinal edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Ischemia
- What is being tested?
- optical coherence tomography
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Chart Review of patients treated b/o retinal vessel occlusion, who were examined with optical coherence tomography
Who may be able to join
- acute Retinal vessel occlusion on one eye
- healthy contralateral eye
- examined with spectral Domain optical coherence tomography
Who cannot join
- retinal occlusion older than 1 week
- OCT Image not obtainable/missing
Trial locations and contacts
1 site in 1 country.
Olga Furashova contact
Germany1 site, 1 recruiting
- Recruiting
University Eye Hospital
Dresden, 01307
Egbert Matthé, MD, +493514583381, egbert.matthe@uniklinikum-dresden.de
About this study
Official title: Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion - A Pilot Study of Detecting Ischemia in OCT
Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. Intracellular edema may develop and decrease transparency of those layers, showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal reflectivity changes as a result of retinal edema. The investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.
Read the detailed description
Several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades. In some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion. State of the art to Diagnose the severity of retinal ischemia is lfuorescein angiography. However, this technique is invasive and might cause Problems like anaphylactic shock. Optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion. The study hope to find criteria by which such a classification can be constructed.
- Conditions
- Retinal Ischemia
- Being tested
- optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomographyOther
measurement of reflectivity in different retinal layers based on optical coherence tomography findings
What is being measured
The primary outcome is the main question the study is designed to answer.
reflectivity
optical density of different retinal layers
Measured: December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 May 2017
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal IschemiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.med. Egbert Matthé, Technische Universität Dresden
- Investigators
- Egbert Matthé, MD, Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061526
- Sponsor's protocol ID
- EK 417102016
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2017
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matthe E, Wittig D, Kuhn M, Eulitz P, Schoen K, Sandner D, Furashova O. Manual measurement of SD-OCT images of hyperreflective retinal layers in acute retinal vessel occlusion is reliable, repeatable and reproducible. Sci Rep. 2025 Oct 3;15(1):34471. doi: 10.1038/s41598-025-20086-7.
PubMed 41044164
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion - A Pilot Study of Detecting Ischemia in OCT
- ClinicalTrials.gov ID
- NCT03061526
- Acronym / sponsor ID
- EK 417102016
- Conditions
- Retinal Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Feb 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.
Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. Intracellular edema may develop and decrease transparency of those layers, showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal reflectivity changes as a result of retinal edema. The investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.
Detailed description
Several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades. In some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion. State of the art to Diagnose the severity of retinal ischemia is lfuorescein angiography. However, this technique is invasive and might cause Problems like anaphylactic shock. Optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion. The study hope to find criteria by which such a classification can be constructed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chart Review of patients treated b/o retinal vessel occlusion, who were examined with optical coherence tomography
Key inclusion criteria (3 listed)
- acute Retinal vessel occlusion on one eye
- healthy contralateral eye
- examined with spectral Domain optical coherence tomography
Key exclusion criteria (2 listed)
- retinal occlusion older than 1 week
- OCT Image not obtainable/missing
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 tomographymeasurement of reflectivity in different retinal layers based on optical coherence tomography findings | Other | – |
Primary outcome
reflectivity
Time frame: December 2017
optical density of different retinal layers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Derived from this study: PubMed 41044164Matthe E, Wittig D, Kuhn M, Eulitz P, Schoen K, Sandner D, Furashova O. Manual measurement of SD-OCT images of hyperreflective retinal layers in acute retinal vessel occlusion is reliable, repeatable and reproducible. Sci Rep. 2025 Oct 3;15(1):34471. doi: 10.1038/s41598-025-20086-7.
- Individual participant dataSharing planned: No
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RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
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New Non-invasive Modalities for Assessing Retinal Structure and Function
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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.
Olga Furashova contact
Egbert Matthé, MD principal investigator
Technische Universität Dresden
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 Ischemia, run by Technische Universität Dresden at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Egbert Matthé, MD (+493514583381, egbert.matthe@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reflectivity (time frame: December 2017). 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 NCT03061526, which also lists 1 linked publication.
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 2 Mar 2023.