Google Maps

NCT07716930

Overview

NCT ID: NCT07716930
Lead Sponsor: Kemal TutkavulOTHER
Official Title: Retina-Based Biomarkers in Epilepsy: Structural and Microvascular OCT Changes and Inflammatory Markers (sCD14, sCD163, CCL2, IL-1β) in Relation to Pathophysiology, Phenotype, Prognosis, and Drug-Resistant Epilepsy (DRE)
Brief 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).
Conditions

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 21, 2026Actual
Start Date: Jul 1, 2026Actual
Primary Completion Date: Jan 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 250Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Saglik Bilimleri University Haydarpasa Numune Education and Research Hospital Neurology Clinic

Similar Studies

Participant Group/Arms

Epilepsy Group

Adults (n=150) aged 18 to 40 years with epilepsy for at least 1 year and currently receiving at least one antiseizure medication. Participants in this cohort will complete NHS3 and LAEP-TR assessments at baseline and at 18 months.

Control Group 1

Adults (n=50) aged 18 to 40 years with migraine, medication-overuse headache, or neuralgia who are currently receiving at least one antiseizure medication for a non-epileptic indication and have no history of epilepsy or unprovoked seizures.

Control Group 2(HC)

Healthy volunteers (n=50) aged 18 to 40 years with no known neurological or ophthalmological disease.