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NCT07716930Enrolling by invitation

Retinal OCT Changes and Biomarkers in Drug-Resistant Epilepsy

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)

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
250 (estimated)
First submitted
26 Jun 2026
Start date
1 Jul 2026
Primary completion date
Jan 2028
Lead sponsor
Kemal Tutkavul
Diseases
Epilepsy
NCT number
NCT07716930

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From 1 Jul 2026 to the primary completion date, Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of ocular surgery, ocular trauma, glaucoma, retinal disease, optic neuropathy, or severe refractive error, defined as spherical equivalent greater than ±6.0 diopters
  • Multiple sclerosis, Parkinson's disease, dementia, brain tumor, stroke, optic neuritis, or other major neurological disorders
  • Diabetes mellitus, uncontrolled hypertension, or other systemic vascular, metabolic diseases that may affect retinal or OCTA parameters

Age

  • Age younger than 18 years or older than 40 years

Other

  • Inability or unwillingness to provide written informed consent
  • Media opacity or poor image quality preventing reliable OCT or OCTA assessment
  • Vigabatrin or Valproate use
  • Evidence of visual pathway lesions on MRI
  • Chronic alcohol or psychoactive substance abuse
  • Inability to undergo OCT or OCTA examination because of cognitive, behavioral, or physical limitations

Who the study is looking for

  • 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

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Saglik Bilimleri University Haydarpasa Numune Education and Research Hospital Neurology Clinic
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.