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Status unknownNCT02196532Updated Jul 22, 2014

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

An observational study in Migraine, sponsored by Yifan Feng. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-22.

Sponsored by Yifan Feng · Observational

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine

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Keywords

  • retinal nerve fiber layer thickness
  • optical coherence tomography
  • migraine
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's planned enrollment of 500 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Yifan Feng is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Migraine patients and healthy subjects were included and underwent OCT examinations

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • migraine group

    Patients with migraine

    Device: Device: Optical coherence tomography

  • healthy control

    Sex- and agematched healthy subjects

    Device: Device: Optical coherence tomography

Interventions

  • DeviceDevice: Optical coherence tomography
06

What researchers measure

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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Zhongshan hospital, Fudan University
    Shanghai, Shanghai 200032, China
    • Yifan Feng, PhD · Contact · wzafengyifan@163.com · 862164041990
    • Yifan Feng, PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02196532
Lead sponsor
Yifan Feng
Collaborators
Fudan University
Responsible party
Yifan Feng (Zhongshan hospital, Fudan University, Wenzhou Medical University) — Sponsor-investigator
First posted
Jul 22, 2014
Start date
Jul 2014
Primary completion
Jul 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Jul 22, 2014

Study contacts

Yifan Feng, PhD
Contact
wzafengyifan@163.com
862164041990
Yifan Feng, PhD
principal investigator · Fudan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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