Optical Coherence Tomography Findings in Migraine

NCT05332431 | Unknown

• 1 other identifier: OCT in migraine
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control. This will be accomplished by comparing the optic nerve head (ONH) parameters, RNFL thickness, and ocular perfusion pressure (OPP) in migraine patients with age and sex matched healthy control.

Conditions

Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (1)

• Changes in retinal nerve fiber layer thickness (RNFL) measured by OCT.

  Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters: Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. 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°) will be measured by OCT.

  Baseline

Secondary Outcomes (1)

• Correlations of OCT findings in patients with migraine with migraine severity.

  Baseline

Study Arms (2)

Patients with Migraine

Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University.

Device: Optical coherence tomography (OCT)

Control

Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison.

Device: Optical coherence tomography (OCT)

Interventions

Optical coherence tomography (OCT) DEVICE

Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters: Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. 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°) will be measured by OCT.

Control; Patients with Migraine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University. 2. Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison.

You may qualify if:

• All patients fulfill the criteria of case definition of migraine with aura and migraine without aura.
• Gender: both sexes are included.
• Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.
• Willing and able to provide informed consent

You may not qualify if:

• Unable to give informed consent.
• History of chronic psychiatric or neurological disorder as patients with history of central nervous system disorders including brain tumours, infarction, epilepsy, Alzheimer's disease, and any type of headache except for migraine.
• Patients with known systemic diseases (such as diabetes mellitus and hypertension).
• Patients with known ophthalmic disorders, refractive error exceeding ± 3.0 diopters and had previously undergone any type of eye surgery. Those with optic disc anomaly, hazy media, and any retinal disease

Sponsors & Collaborators

• Assiut University: lead

Related Publications (30)

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MeSH Terms

Conditions

Migraine with Aura; Migraine without Aura

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Central Study Contacts

Reda B Abdelrasoul, professor

CONTACT

01008336450; redaalbadry02@gmail.com

Nourelhoda A Ahmed, lecturer

CONTACT

01063981139; nourelhodaahmed@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Resident doctor of Neurology

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: April 18, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: June 1, 2023
• Last Updated: April 18, 2022

Record last verified: 2022-04