Retinal OCT Changes and Biomarkers in Drug-Resistant Epilepsy

Sponsor
Kemal Tutkavul
Study ID
NCT07716930
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Study Details

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).

Key Dates

First listed
Jul 21, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: Control Group 2(HC)
    Healthy volunteers (n=50) aged 18 to 40 years with no known neurological or ophthalmological disease.

Primary Outcome Measure

Annualized percentage change in peripapillary retinal nerve fiber layer thickness measured by OCT [ Time Frame: Baseline to 18 months after enrollment. ]

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