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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saglik Bilimleri University Haydarpasa Numune Education and Research Hospital Neurology Clinic Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.