Retinal Vein OcclusionNCT02523339
Study of Retinal Oxygenation in Central Retinal Vein Occlusion
An observational study of Retinal Vein Occlusion, run by University of Iceland at 8 sites in 7 countries.
Trial summary
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion
- How many people
- 117 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Oct 2014to 3 Nov 2020
- 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: Patients with suspected central retinal vein occlusion (CRVO) will be invited to participate.
Who may be able to join
- Suspected central retinal vein occlusion.
- Informed consent for participation.
- No treatment before the first oximetry measurement.
Who cannot join
- History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
- History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
- Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Switzerland2 sites
Eye Clinic of the University Hospital Basel
Basel, Canton of Basel-City, 4055
Clinical Research Center Memorial A. de Rothschild
Geneva, 1208
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Czechia1 site
Department of Ophthalmology, University Hospital and Faculty of Medicine and Dentistry, Palacky University Olomouc
Olomouc, 77900
Denmark1 site
Aarhus University. Department of Clinical Medicine - The Department of Ophthalmology
Aarhus, 8000
Iceland1 site
University of Iceland / Landspitali, Dept. of Ophthalmology
Reykjavik, 101
United Kingdom1 site
Aston University School of Life and Health Sciences
Birmingham, B4 7ET
About this study
Official title: Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.
- Conditions
- Retinal Vein Occlusion
- Medical subject headings
- Retinal Vein Occlusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vessel oxygen saturation
Measured: 12 months
Visual acuity
Measured: 12 months
Central retinal thickness
Measured: 12 months
Presence or absence of ocular neovascularisation
As determined by gonioscopic examination
Measured: 12 months
Secondary outcomes (12)
Retinal vessel oxygen saturation
Measured: Baseline
Visual acuity
Measured: Baseline
Central retinal thickness
Measured: Baseline
Presence or absence of ocular neovascularisation
As determined by gonioscopic examination
Measured: Baseline
Retinal vessel oxygen saturation
Measured: 3 months
Visual acuity
Measured: 3 months
Central retinal thickness
Measured: 3 months
Presence or absence of ocular neovascularisation
As determined by gonioscopic examination
Measured: 3 months
Retinal vessel oxygen saturation
Measured: 6 months
Visual acuity
Measured: 6 months
Central retinal thickness
Measured: 6 months
Presence or absence of ocular neovascularisation
As determined by gonioscopic examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2018
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein OcclusionStudies 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Aston University, University of Jena, Medical University of Vienna, University of Aarhus, Clinical Research Center Memorial A. de Rothschild, Palacky University, University of Toyama
- Responsible party
- Principal investigator, Sveinn Hakon Hardarson, University of Iceland
- Investigators
- Sveinn H. Hardarson, PhD, Principal investigator, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523339
- Sponsor's protocol ID
- UI-CRVO-2015
- Status last verified
- Feb 2021
- First submitted
- 7 Aug 2015
- Last updated
- 12 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Retinal Oxygenation in Central Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT02523339
- Acronym / sponsor ID
- UI-CRVO-2015
- Conditions
- Retinal Vein Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Aston University, University of Jena, Medical University of Vienna, University of Aarhus, Clinical Research Center Memorial A. de Rothschild, Palacky University, University of Toyama
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 14 Aug 2015 (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.
The purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. Retinal oximetry is performed with fundus camera based oximeters. The study will not entail change in treatment of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected central retinal vein occlusion (CRVO) will be invited to participate.
Key inclusion criteria (3 listed)
- Suspected central retinal vein occlusion.
- Informed consent for participation.
- No treatment before the first oximetry measurement.
Key exclusion criteria (3 listed)
- History of other retinal disease. Glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered.
- History of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. Examples: Known COPD or carotid stenosis. Subjects with high blood pressure will not be excluded but blood pressure should be registered.
- Poor quality images will be excluded based on the images themselves. Therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal vessel oxygen saturation
Time frame: 12 months
Visual acuity
Time frame: 12 months
Central retinal thickness
Time frame: 12 months
Presence or absence of ocular neovascularisation
Time frame: 12 months
As determined by gonioscopic examination
12 secondary outcomes
Retinal vessel oxygen saturation
Time frame: Baseline
Visual acuity
Time frame: Baseline
Central retinal thickness
Time frame: Baseline
Presence or absence of ocular neovascularisation
Time frame: Baseline
Retinal vessel oxygen saturation
Time frame: 3 months
Visual acuity
Time frame: 3 months
Central retinal thickness
Time frame: 3 months
Presence or absence of ocular neovascularisation
Time frame: 3 months
Retinal vessel oxygen saturation
Time frame: 6 months
Visual acuity
Time frame: 6 months
Central retinal thickness
Time frame: 6 months
Presence or absence of ocular neovascularisation
Time frame: 6 months
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 12 Feb 2021.
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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.
Sveinn H. Hardarson, PhD principal investigator
University of Iceland
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Vein Occlusion, run by University of Iceland at 8 sites in 7 countries.
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 3 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 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland, Austria, Czechia, Denmark, Germany and 2 more countries. 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?
Retinal vessel oxygen saturation (time frame: 12 months). The study lists 4 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 12 Feb 2021.