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

NCT02196532 | Unknown

• 1 other identifier: FYF20140717
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

retinal nerve fiber layer thickness; optical coherence tomography; migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (2)

migraine group

Patients with migraine

Device: Device: Optical coherence tomography

healthy control

Sex- and agematched healthy subjects

Device: Device: Optical coherence tomography

Interventions

Device: Optical coherence tomography DEVICE

healthy control; migraine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Migraine patients and healthy subjects were included and underwent OCT examinations

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yifan Feng: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yifan Feng, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Feng, PhD

CONTACT

862164041990; wzafengyifan@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zhongshan hospital, Fudan University

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

CN (1)