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