MigraineNCT02196532
Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies
An observational study of Migraine, run by Yifan Feng at 1 site in China.
Trial summary
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Device: Optical coherence tomography
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2015
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migraine patients and healthy subjects were included and underwent OCT examinations
Who may be able to join
- case-control studies;
- patients with Migraine were compared with healthy controls;
- all subjects underwent RNFL thickness measurement by OCT;
- studies should provide the data of peripapillary RNFL thickness;
- sample size ≥10 in each group.
Who cannot join
- authors did not make RNFL measurements;
- study without healthy control group;
- the outcome values can not be used for meta-analysis;
- duplicated articles.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Yifan Feng, PhD, 862164041990, wzafengyifan@163.com
Yifan Feng, PhD
About this study
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in migraine, is a common hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic nervous system. The pathophysiology of migraine has not been fully clarified, but there is increasing evidence that episodes of migraine with aura are initiated by a focal reduction in cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere. Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon, the chronic nature of the migraine might cause permanent structural abnormalities of the brain and also of the retina, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in migraine patients, the investigators performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of migraine patients and in the healthy control groups.
- Conditions
- Migraine
- Being tested
- Device: Optical coherence tomography
- Keywords
- retinal nerve fiber layer thickness, optical coherence tomography, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Optical coherence tomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| migraine group | Patients with migraine Receives: Device: Device: Optical coherence tomography | |
| healthy control | Sex- and agematched healthy subjects Receives: Device: Device: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness
Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifan Feng
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Sponsor-investigator, Yifan Feng, Wenzhou Medical University
- Investigators
- Yifan Feng, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196532
- Sponsor's protocol ID
- FYF20140717
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies
- ClinicalTrials.gov ID
- NCT02196532
- Acronym / sponsor ID
- FYF20140717
- Conditions
- Migraine
- Keywords
- retinal nerve fiber layer thickness, optical coherence tomography, migraine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yifan FengUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 22 Jul 2014 (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.
Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in migraine, is a common hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic nervous system. The pathophysiology of migraine has not been fully clarified, but there is increasing evidence that episodes of migraine with aura are initiated by a focal reduction in cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere. Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon, the chronic nature of the migraine might cause permanent structural abnormalities of the brain and also of the retina, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in migraine patients, the investigators performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of migraine patients and in the healthy control groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| migraine group | – | Device: Device: Optical coherence tomographyPatients with migraine |
| healthy control | – | Device: Device: Optical coherence tomographySex- and agematched healthy subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine patients and healthy subjects were included and underwent OCT examinations
Key inclusion criteria (5 listed)
- case-control studies;
- patients with Migraine were compared with healthy controls;
- all subjects underwent RNFL thickness measurement by OCT;
- studies should provide the data of peripapillary RNFL thickness;
- sample size ≥10 in each group.
Key exclusion criteria (4 listed)
- authors did not make RNFL measurements;
- study without healthy control group;
- the outcome values can not be used for meta-analysis;
- duplicated articles.
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 |
|---|---|---|
| Device: Optical coherence tomography | Device | healthy control, migraine group |
Primary outcome
Retinal Nerve Fiber Layer Thickness
Time frame: Baseline
Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°)was measured by OCT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
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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.
Yifan Feng, PhD principal investigator
Fudan University
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 Migraine, run by Yifan Feng at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 2014. 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 China. 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 Yifan Feng, PhD (862164041990, wzafengyifan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness (time frame: Baseline). 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 22 Jul 2014.