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Enrolling By Invitation NCT07716930

Retinal OCT Changes and Biomarkers in Drug-Resistant Epilepsy

Conditions: Epilepsy (Treatment Refractory), Epilepsy

Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Enrollment: 250
Sponsor: Kemal Tutkavul

Location: Saglik Bilimleri University Haydarpasa Numune Education and Research Hospital Neurology Clinic Istanbul

Summary

This prospective, longitudinal observational study investigates whether epilepsy involves a progressive neurodegenerative process. Retinal structural and microvascular changes assessed by optical coherence tomography (OCT) and optical coherence (OCTA) will be analyzed alongside inflammatory biomarkers (sCD14, sCD163, CCL2, IL-1β). The study aims to explore their association with epilepsy pathophysiology, clinical phenotype, prognosis, and drug-resistant epilepsy (DRE). Among participants with epilepsy, seizure severity and antiseizure medication-related adverse-effect burden will also be assessed longitudinally using the National Hospital Seizure Severity Scale (NHS3) and the Turkish version of Liverpool Adverse Events Profile (LAEP-TR).

Eligibility Criteria

Inclusion Criteria: * Age between 18 and 40 years * Ability to provide written informed consent * For the epilepsy group: diagnosis of epilepsy for at least 1 year * For the epilepsy group: treatment with at least one antiseizure medication for at least 1 year * For the disease-control group: diagnosis of migraine, analgesic-overuse headache, or neuralgia * For the disease-control group: current treatment with at least one antiseizure medication for a non-epileptic indication * For the disease-control group: no history of epilepsy or unprovoked seizures * For the healthy-control group: no history of epilepsy, major neurological disease, ophthalmological disease, or regular antiseizure medication use Exclusion Criteria: * Age younger than 18 years or older than 40 years * Inability or unwillingness to provide written informed consent * History of ocular surgery, ocular trauma, glaucoma, retinal disease, optic neuropathy, or severe refractive error, defined as spherical equivalent greater than ±6.0 diopters * Media opacity or poor image quality preventing reliable OCT or OCTA assessment * Vigabatrin or Valproate use * Multiple sclerosis, Parkinson's disease, dementia, brain tumor, stroke, optic neuritis, or other major neurological disorders * Evidence of visual pathway lesions on MRI * Diabetes mellitus, uncontrolled hypertension, or other systemic vascular, metabolic diseases that may affect retinal or OCTA parameters * Chronic alcohol or psychoactive substance abuse * Inability to undergo OCT or OCTA examination because of cognitive, behavioral, or physical limitations

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07716930). StuddyBuddy aggregates publicly available trial information.