Optical Coherence TomographyNCT03390205
OCT Angiography in Vitreo and Chorioretinal Pathologies
An observational study of Optical Coherence Tomography, run by CRG UZ Brussel.
Trial summary
In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Optical Coherence Tomography
- What is being tested?
- Optical coherence tomography angiography under dark and light adaptation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Mar 2019
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Patients with pathology in vitreo and chorioretinal complex and age matched controls
Who may be able to join
- Patient with vitreo and chorioretinal pathology, aged-adapted controls
Who cannot join
- Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence Tomography Angiography in Vitreo and Chorioretinal Pathologies Under the Influence of Dark and Light Adaptation
In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.
- Conditions
- Optical Coherence Tomography
- Being tested
- Optical coherence tomography angiography under dark and light adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiography under dark and light adaptationDiagnostic test
Optical coherence tomography angiography under dark and light adaptation with pupil dilatation
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation | |
| Controls | Not described Receives: Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel density
Vessel density measurements of macula and optic nerve
Measured: 5 minutes after intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study startFeb 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CRG UZ Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Nelis, CRG UZ Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390205
- Sponsor's protocol ID
- 2812201748151
- Status last verified
- Dec 2017
- First submitted
- 28 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography in Vitreo and Chorioretinal Pathologies Under the Influence of Dark and Light Adaptation
- ClinicalTrials.gov ID
- NCT03390205
- Acronym / sponsor ID
- 2812201748151
- Conditions
- Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CRG UZ BrusselUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 4 Jan 2018 (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.
In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation |
| Controls | – | Diagnostic Test: Optical coherence tomography angiography under dark and light adaptation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with pathology in vitreo and chorioretinal complex and age matched controls
Key inclusion criteria (1 listed)
- Patient with vitreo and chorioretinal pathology, aged-adapted controls
Key exclusion criteria (1 listed)
- Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide
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 angiography under dark and light adaptationOptical coherence tomography angiography under dark and light adaptation with pupil dilatation | Diagnostic test | Controls, Patients |
Primary outcome
Vessel density
Time frame: 5 minutes after intervention ends
Vessel density measurements of macula and optic nerve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Optical Coherence Tomography, run by CRG UZ Brussel.
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: status not confirmed, as of the sponsor's last update on 4 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Pieter Jan Nelis, MD (0032494354198, nelispieter@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel density (time frame: 5 minutes after intervention ends). 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 4 Jan 2018.