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Trial record 11 of 15 for:    CADASIL

Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies

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ClinicalTrials.gov Identifier: NCT02196532
Recruitment Status : Unknown
Verified July 2014 by Yifan Feng, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Collaborator:
Fudan University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University

Brief 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. 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.

Condition or disease Intervention/treatment
Migraine Device: Device: Optical coherence tomography

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
migraine group
Patients with migraine
Device: Device: Optical coherence tomography
healthy control
Sex- and agematched healthy subjects
Device: Device: Optical coherence tomography



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Migraine patients and healthy subjects were included and underwent OCT examinations
Criteria

Inclusion Criteria:

  1. case-control studies;
  2. patients with Migraine were compared with healthy controls;
  3. all subjects underwent RNFL thickness measurement by OCT;
  4. studies should provide the data of peripapillary RNFL thickness;
  5. sample size ≥10 in each group.

Exclusion Criteria:

  1. authors did not make RNFL measurements;
  2. study without healthy control group;
  3. the outcome values can not be used for meta-analysis;
  4. duplicated articles.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02196532


Contacts
Contact: Yifan Feng, PhD 862164041990 wzafengyifan@163.com

Locations
China, Shanghai
Zhongshan hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yifan Feng, PhD    862164041990    wzafengyifan@163.com   
Principal Investigator: Yifan Feng, PhD         
Sponsors and Collaborators
Yifan Feng
Fudan University
Investigators
Principal Investigator: Yifan Feng, PhD Fudan University

Responsible Party: Yifan Feng, Zhongshan hospital, Fudan University, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02196532     History of Changes
Other Study ID Numbers: FYF20140717
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

Keywords provided by Yifan Feng, Wenzhou Medical University:
retinal nerve fiber layer thickness
optical coherence tomography
migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases