Tear Biomarkers for Migraine

Novel Diagnostic and Treatment Response Biomarkers in Tear Fluid of Migraine Patients

The goal of this observational monocentric study is to investigate tear and serum biomarkers in patients with migraine compared with healthy controls, and to explore their potential diagnostic, clinical, and predictive value. In addition to the cross-sectional evaluation, a longitudinal subgroup analysis will be conducted to assess biomarker changes over time during treatment with anti- Calcitonin Gene-Related Peptide (anti-CGRP) therapies.

Inclusion criteria patients with migraine

• Male or female participants aged ≥ 18 years;
• Diagnosis of migraine according to International Classification of Headache Disorders (ICHD) criteria;
• Clinical indication, according to routine practice, for treatment with anti-CGRP monoclonal antibodies or gepants (only for the longitudinal subgroup);
• Ability and willingness to provide written informed consent. Inclusion criteria for healthy controls
• Male or female participants aged ≥ 18 years;
• Subjects, without migraine;
• Ability and willingness to provide written informed consent.

Exclusion criteria (for both patients with migraine and healthy controls)

• Fulfillment of ICHD diagnostic criteria for secondary headaches;
• Active inflammatory ocular diseases;
• Severe abnormalities in tear production;
• Systemic inflammatory diseases that may interfere with biomarker interpretation.